BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    ENERTRON CPR JACK

    K Number: K024215 · Decision May 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    511

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    Basic Information

    Device Name
    ENERTRON CPR JACK
    K Number
    K024215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enertron Engineering Co.
    Date Received
    December 20, 2002
    Decision Date
    May 14, 2004
    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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