Philips Medizin Systeme Boblingen GmbH
Andover, MA, US
Philips Medizin Systeme Boblingen GmbH appears in FDA device records in Andover, MA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Philips Medizin Systeme Boblingen GmbH between 2001 and 2026. The busiest year on record is 2025, with 5. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | DQA | Substantially Equivalent | |
| K253654 | IntelliVue Measurement Rack 6000 (867317) | MSX | Substantially Equivalent | |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | MHX | Substantially Equivalent | |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | MHX | Substantially Equivalent | |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | MHX | Substantially Equivalent | |
| K241890 | Philips Holter Analysis System | MLO | Substantially Equivalent | |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | DSA | Substantially Equivalent | |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | DPS | Substantially Equivalent | |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | MHX | Substantially Equivalent | |
| K211900 | Patient Information Center iX | MHX | Substantially Equivalent | |
| K151736 | Philips IntelliVue GuardianSoftware | DXJ | Substantially Equivalent | |
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | HGM | Substantially Equivalent | |
| K113657 | INTELLIVUE PATIENT MONITOR | MHX | Substantially Equivalent | |
| K102958 | PHILIPS AVALON FETAL MONITOR | HGM | Substantially Equivalent | |
| K102562 | INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 | MHX | Substantially Equivalent | |
| K090360 | PHILIPS M3001A MULTI MEASUREMENT SERVER | DQA | Substantially Equivalent | |
| K083228 | PHILIPS INTELLIVUE MP5 PATIENT MONITOR | MHX | Substantially Equivalent | |
| K060541 | THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS | MHX | Substantially Equivalent | |
| K042845 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS | MSX | Substantially Equivalent | |
| K032858 | THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. | DSI | Substantially Equivalent | |
| K031481 | THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 | MHX | Substantially Equivalent | |
| K013624 | MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I | MHX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
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