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

    TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000

    K Number: K894540 · Decision Oct 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    80
    Review Days
    84

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    Basic Information

    Device Name
    TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
    K Number
    K894540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Physio-Control Corp.
    Date Received
    July 20, 1989
    Decision Date
    October 12, 1989
    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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