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Data / Medical devices / Germany / Pulsion Medical Systems Se

Pulsion Medical Systems Se: FDA-registered device maker in Aschheim, Germany, 3 510(k) clearances

Pulsion Medical Systems Se is registered with the FDA (registration 3003263092) in Aschheim, Germany. It lists 39 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2018. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Pulsion Medical Systems Se
FDA registration number
3003263092
Address
Einstein Ring 30, Aschheim, Germany, 85609
Owner or operator
Maquet Critical Care AB (9036213)
Roles
Contract manufacturer, Manufacturer
First device listed
December 6, 2007
Registered through
2026
Brand names listed
CeVOX Module, ITS Housing, Inline Injectate temperature Probe, PICCO Temperature Probe, PiCCO Catheter, PiCCO Module, PulsioFlex Monitor

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Lead Switching, ElectrocardiographDRW2Contract manufactureraccessdata.fda.gov
Alarm, Blood-PressureDSJ2Contract manufactureraccessdata.fda.gov
Amplifier And Signal Conditioner, Transducer SignalDRQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Contract manufactureraccessdata.fda.gov
Analyzer, Spectrum, Electroencephalogram SignalGWS1Contract manufactureraccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Contract manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Contract manufactureraccessdata.fda.gov
Calculator, Pulmonary Function DataBZC2Contract manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Contract manufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Contract manufacturer, Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Contract manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Contract manufactureraccessdata.fda.gov
ElectrocardiographDPS2Contract manufactureraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Contract manufactureraccessdata.fda.gov
Monitor, Carbon-Dioxide, CutaneousLKD2Contract manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Contract manufactureraccessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaKLK2Contract manufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Contract manufactureraccessdata.fda.gov
Monitor, St SegmentMLC2Contract manufactureraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Contract manufactureraccessdata.fda.gov
OximeterDQA2Contract manufactureraccessdata.fda.gov
Probe, ThermodilutionKRB2Contract manufacturer, Manufactureraccessdata.fda.gov
Recorder, Magnetic Tape, MedicalDSH2Contract manufactureraccessdata.fda.gov
Recorder, Paper ChartDSF1Contract manufactureraccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Contract manufactureraccessdata.fda.gov
System, Balloon, Intra-Aortic And ControlDSP2Contract manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Contract manufactureraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Contract manufactureraccessdata.fda.gov
System, Signal IsolationDRJ1Contract manufactureraccessdata.fda.gov
Tester, Electrode, Surface, ElectrocardiographicKRC2Contract manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Contract manufactureraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 21, 2018K171620PiCCO CatheterKRBSubstantially EquivalentPulsion Medical Systems SEaccessdata.fda.gov
January 18, 2018K172259PulsioFlex Monitoring SystemDXGSubstantially EquivalentPulsion Medical Systems SEaccessdata.fda.gov
May 23, 2002K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046KRBSubstantially EquivalentPulsion Medical Systems AGaccessdata.fda.gov

Compare with other makers

Updated February 21, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.