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

    CARDIO-DATA SYSTEM, #MARK III

    K Number: K812149 · Decision Aug 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    6
    Review Days
    34

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    Basic Information

    Device Name
    CARDIO-DATA SYSTEM, #MARK III
    K Number
    K812149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardio Data
    Date Received
    July 28, 1981
    Decision Date
    August 31, 1981
    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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