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

    MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER

    K Number: K895525 · Decision Jan 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    14
    Review Days
    136

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    Basic Information

    Device Name
    MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER
    K Number
    K895525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5325
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Matrix Medica, Inc.
    Date Received
    September 12, 1989
    Decision Date
    January 26, 1990
    Product Code
    DRL
    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
    DRL Tester, Defibrillator

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