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

    THUMPER

    K Number: K972525 · Decision Oct 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    THUMPER
    K Number
    K972525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Michigan Instruments, Inc.
    Date Received
    July 7, 1997
    Decision Date
    October 2, 1997
    Product Code
    DRM
    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
    DRM Compressor, Cardiac, External

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    Other Clearances by Michigan Instruments, Inc.

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    K851139 THUMPER CARDIOPULMONARY RESUSCITATOR 1005
    K833879 CARDIOPULMONARY RESUSCITATOR
    K811909 CARDIOPULMUNARY RESUSCITATOR