Pulsion Medical Systems SE
Aschheim, DE
PULSION MEDICAL SYSTEMS SE appears in FDA device records in Aschheim, DE. FDA records list 4 510(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 4 510(k) clearances for Pulsion Medical Systems SE between 2012 and 2020. The busiest year on record is 2018, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | DXG | Substantially Equivalent | |
| K171620 | PiCCO Catheter | KRB | Substantially Equivalent | |
| K172259 | PulsioFlex Monitoring System | DXG | Substantially Equivalent | |
| K122121 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE | DXG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003263092 | 3003263092 | PULSION MEDICAL SYSTEMS SE | Einstein Ring 30, Aschheim 85609 DE | 2026 | and 29 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
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- GWSAnalyzer, Spectrum, Electroencephalogram Signal
- ORTBurst Suppression Detection Software For Electroencephalograph
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- BZCCalculator, Pulmonary Function Data
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- BZQMonitor, Breathing Frequency
- LKDMonitor, Carbon-Dioxide, Cutaneous
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLCMonitor, St Segment
- MLDMonitor, St Segment With Alarm
- DQAOximeter
- KRBProbe, Thermodilution
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- KOIStimulator, Nerve, Peripheral, Electric
- DSPSystem, Balloon, Intra-Aortic And Control
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- DRJSystem, Signal Isolation
- KRCTester, Electrode, Surface, Electrocardiographic
- DRSTransducer, Blood-Pressure, Extravascular
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
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