BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM

    K Number: K141809 · Decision Oct 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    9
    Review Days
    112

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    Basic Information

    Device Name
    RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
    K Number
    K141809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Defibtech, LLC
    Date Received
    July 7, 2014
    Decision Date
    October 27, 2014
    Product Code
    DRM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRM Compressor, Cardiac, External

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    Other Clearances by Defibtech, LLC

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    K081259 DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
    K033896 DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
    K033144 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
    K013896 SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA