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

    GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

    K Number: K921929 · Decision Sep 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    13
    Review Days
    147

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    Basic Information

    Device Name
    GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)
    K Number
    K921929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Devices
    Date Received
    April 24, 1992
    Decision Date
    September 18, 1992
    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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