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

    HOLTA-MED INFORMER PLAYBACK

    K Number: K832354 · Decision Jan 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    2
    Review Days
    193

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    Basic Information

    Device Name
    HOLTA-MED INFORMER PLAYBACK
    K Number
    K832354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Holta-Med
    Date Received
    July 18, 1983
    Decision Date
    January 27, 1984
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Holta-Med

    K Number Device Name
    K832395 HOLTA-MED RECORDER