BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Infinity Acute Care System (IACS) Monitoring Solution - M500 Docking Station

    Reg #: 3005783425 · FEI: 3005783425 · Expires 2025
    View on FDA
    Products
    33
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    33

    Registration Details

    Registration Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Registration Number
    3005783425
    FEI Number
    3005783425
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 TECH DRIVE
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203088

    Owner / Operator

    Firm Name
    Draeger Medical Systems, Inc.
    Operator Number
    9070398
    Address
    6 Tech Drive
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Monitor, St Segment With Alarm MLD
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, Apnea, Facility Use FLS
    Oximeter DQA
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Plethysmograph, Impedance DSB
    Stimulator, Nerve, Peripheral, Electric KOI
    Catheter, Oximeter, Fiber-Optic DQE
    Burst Suppression Detection Software For Electroencephalograph ORT
    Computer, Blood-Pressure DSK
    Monitor, Breathing Frequency BZQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    System, Network And Communication, Physiological Monitors MSX
    Gas-Machine, Anesthesia BSZ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Recorder, Paper Chart DSF
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Reduced- Montage Standard Electroencephalograph OMC
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Stimulator, Muscle, Powered IPF
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    Infinity Acute Care System (IACS) Monitoring Solution - M500 Docking Station Y-Adapter P2500 Power Supply Infinity Acute Care System (IACS) Monitoring Solution - C500 Cockpit PS120 Desktop Power Supply Infinity Acute Care System (IACS) Monitoring System Infinity M-Cable Masimo Rainbow Set Infinity Acute Care System (IACS) Monitoring Solution - M540 Infinity Acute Care System (IACS) Monitoring Solution - C700 Cockpit

    Establishment Types

    Manufacture Medical Device