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

    CRITERION II RHYTHM PROFILE MONITOR

    K Number: K803315 · Decision Jan 22, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    7
    Review Days
    23

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    Basic Information

    Device Name
    CRITERION II RHYTHM PROFILE MONITOR
    K Number
    K803315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Dart Medical Equipment
    Date Received
    December 30, 1980
    Decision Date
    January 22, 1981
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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