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

    PULSE-AID DEVICE

    K Number: K843977 · Decision Feb 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    PULSE-AID DEVICE
    K Number
    K843977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    James J. Lally
    Date Received
    October 5, 1984
    Decision Date
    February 1, 1985
    Product Code
    LIX
    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
    LIX Aid, Cardiopulmonary Resuscitation

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