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

    HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

    K Number: K880780 · Decision May 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    76

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    Basic Information

    Device Name
    HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
    K Number
    K880780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5325
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    First Medical Devices Corp.
    Date Received
    February 26, 1988
    Decision Date
    May 12, 1988
    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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    K871136 HEARTSTART 2000, MANUAL DEFIBRILLATOR
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