Philips Medizin Systeme Boeblingen GmbH
BOEBLINGEN Baden-Wurttemberg, DE
Philips Medizin Systeme Boeblingen GmbH appears in FDA device records in BOEBLINGEN Baden-Wurttemberg, DE. FDA records list 48 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 48 510(k) clearances for Philips Medizin Systeme Boeblingen GmbH between 2004 and 2026. The busiest year on record is 2005, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 4 |
| 2005 | 7 |
| 2006 | 6 |
| 2008 | 3 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | MHX | Substantially Equivalent | |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | MHX | Substantially Equivalent | |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | HGM | Substantially Equivalent | |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | MHX | Substantially Equivalent | |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | MHX | Substantially Equivalent | |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) | MHX | Substantially Equivalent | |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 | MHX | Substantially Equivalent | |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | DXJ | Substantially Equivalent | |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | MHX | Substantially Equivalent | |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 | MHX | Substantially Equivalent | |
| K190624 | EarlyVue VS30 | DSJ | Substantially Equivalent | |
| K182637 | Philips IntelliVue XDS Software | MSX | Substantially Equivalent | |
| K181831 | IntelliVue Multi-Measurement Module MMX | MHX | Substantially Equivalent | |
| K173941 | IntelliSpace Perinatal Rev.K.00 | HGM | Substantially Equivalent | |
| K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension | MHX | Substantially Equivalent | |
| K180534 | Philips IntelliVue GuardianSoftware | DXJ | Substantially Equivalent | |
| K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Extension | CCK | Substantially Equivalent | |
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable | MHX | Substantially Equivalent | |
| K161767 | Philips IntelliVue GuardianSoftware | DXJ | Substantially Equivalent | |
| K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 | MHX | Substantially Equivalent | |
| K151681 | IntelliVue Patient Monitor | DSI | Substantially Equivalent | |
| K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors | MHX | Substantially Equivalent | |
| K150310 | IntelliVue Patient Monitor | DSI | Substantially Equivalent | |
| K131913 | INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC | DRG | Substantially Equivalent | |
| K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | BZQ | Substantially Equivalent | |
| K122439 | INTELLIVUE PATIENT MONITOR | MHX | Substantially Equivalent | |
| K100420 | PHILIPS OBTRACEVUE MODEL SW REV. G.00 | HGM | Substantially Equivalent | |
| K092028 | PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 | HGM | Substantially Equivalent | |
| K081793 | PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER | MHX | Substantially Equivalent | |
| K081937 | PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE | DQA | Substantially Equivalent | |
| K081203 | OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 | HGM | Substantially Equivalent | |
| K063315 | INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 | MHX | Substantially Equivalent | |
| K062392 | PHILIPS MP5 INTELLIVUE PATIENT MONITOR | MHX | Substantially Equivalent | |
| K062137 | MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 | HGM | Substantially Equivalent | |
| K061610 | PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS | MHX | Substantially Equivalent | |
| K060221 | THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS | MHX | Substantially Equivalent | |
| K053522 | PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 | MHX | Substantially Equivalent | |
| K052795 | PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 | HGM | Substantially Equivalent | |
| K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. | DQA | Substantially Equivalent | |
| K052801 | INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 | MHX | Substantially Equivalent | |
| K051366 | PICONIBP OEM MODULE | DXN | Substantially Equivalent | |
| K051106 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS | DXN | Substantially Equivalent | |
| K050762 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 | MHX | Substantially Equivalent | |
| K050141 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS | MHX | Substantially Equivalent | |
| K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A | DQA | Substantially Equivalent | |
| K041235 | PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS | MHX | Substantially Equivalent | |
| K040917 | PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B | CBQ | Substantially Equivalent | |
| K040304 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 | MHX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610816 | 3002807167 | Philips Medizin Systeme Boeblingen GmbH | HEWLETT-PACKARD STRASSE 2, BOEBLINGEN Baden-Wurttemberg D 71034 DE | 2026 | and 66 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRWAdaptor, Lead Switching, Electrocardiograph
- DSJAlarm, Blood-Pressure
- DRQAmplifier And Signal Conditioner, Transducer Signal
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- GWSAnalyzer, Spectrum, Electroencephalogram Signal
- DXQBlood Pressure Cuff
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- BZCCalculator, Pulmonary Function Data
- JQPCalculator/Data Processing Module, For Clinical Use
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- GWQFull-Montage Standard Electroencephalograph
- BXKGas, Calibration (Specified Concentration)
- GWRGenerator, Electroencephalograph Test Signal
- BZQMonitor, Breathing Frequency
- LKDMonitor, Carbon-Dioxide, Cutaneous
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLCMonitor, St Segment
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- DQAOximeter
- DPZOximeter, Ear
- JFLPh Rate Measurement, Carbon-Dioxide
- DSBPlethysmograph, Impedance
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- KRBProbe, Thermodilution
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- BZSStethoscope Head
- LDEStethoscope, Manual
- KOIStimulator, Nerve, Peripheral, Electric
- DSPSystem, Balloon, Intra-Aortic And Control
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- DRJSystem, Signal Isolation
- KRCTester, Electrode, Surface, Electrocardiographic
- DRSTransducer, Blood-Pressure, Extravascular
- HFNTransducer, Pressure, Intrauterine
- HGLTransducer, Ultrasonic, Obstetric
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- EXSUrinometer, Electrical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain