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

    MINIATURIZE CHEST COMPRESSOR (MCC)

    K Number: K102068 · Decision Nov 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    116

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    Basic Information

    Device Name
    MINIATURIZE CHEST COMPRESSOR (MCC)
    K Number
    K102068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Resuscitation International
    Date Received
    July 23, 2010
    Decision Date
    November 16, 2010
    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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