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

    MODELS M1722A, M1723A, M1724A DEFIBRILLATORS

    K Number: K915757 · Decision Jul 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    230
    Review Days
    220

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    Basic Information

    Device Name
    MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
    K Number
    K915757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hewlett-Packard Co.
    Date Received
    December 23, 1991
    Decision Date
    July 30, 1992
    Product Code
    DRO
    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
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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