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

    POCKETCPR

    K Number: K112660 · Decision May 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    16
    Applicant Total
    33
    Review Days
    240

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    Basic Information

    Device Name
    POCKETCPR
    K Number
    K112660
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Medical Corp
    Date Received
    September 13, 2011
    Decision Date
    May 10, 2012
    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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