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

    POCKETCPR

    K Number: K071321 · Decision Sep 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    16
    Applicant Total
    17
    Review Days
    125

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    Basic Information

    Device Name
    POCKETCPR
    K Number
    K071321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Detek, Inc.
    Date Received
    May 10, 2007
    Decision Date
    September 12, 2007
    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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