BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A

    K Number: K091548 · Decision Aug 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    5
    Review Days
    72

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    Basic Information

    Device Name
    AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
    K Number
    K091548
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amco International Manufacturing & Design, Inc.
    Date Received
    May 27, 2009
    Decision Date
    August 7, 2009
    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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    Other Clearances by Amco International Manufacturing & Design, Inc.

    K Number Device Name
    K082861 AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
    K073716 LIFE+CEL OR LIFECEL BATTERY
    K072596 LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
    K071164 LIFE+CEL BATTERY