BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

    K Number: K013896 · Decision Jun 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    9
    Review Days
    208

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    Basic Information

    Device Name
    SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
    K Number
    K013896
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Defibtech, LLC
    Date Received
    November 23, 2001
    Decision Date
    June 19, 2002
    Product Code
    MKJ
    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
    MKJ Automated External Defibrillators (Non-Wearable)

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    K033896 DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
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