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

    HOLTA-MED RECORDER

    K Number: K832395 · Decision Oct 20, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    HOLTA-MED RECORDER
    K Number
    K832395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Holta-Med
    Date Received
    July 19, 1983
    Decision Date
    October 20, 1983
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Holta-Med

    K Number Device Name
    K832354 HOLTA-MED INFORMER PLAYBACK