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

    FIRST MEDIC MODE 610

    K Number: K883584 · Decision Oct 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    7
    Review Days
    45

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    Basic Information

    Device Name
    FIRST MEDIC MODE 610
    K Number
    K883584
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    First Medical Devices Corp.
    Date Received
    August 22, 1988
    Decision Date
    October 6, 1988
    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 First Medical Devices Corp.

    K Number Device Name
    K903657 MODEL 610 MODIFIED
    K895185 FIRST MEDIC MODEL 610P
    K880780 HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
    K871136 HEARTSTART 2000, MANUAL DEFIBRILLATOR
    K871135 HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE
    K860676 HEARTSTART 2000