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

    CMS 6000

    K Number: K792380 · Decision Jan 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    80
    Review Days
    39

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    Basic Information

    Device Name
    CMS 6000
    K Number
    K792380
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Physio-Control Corp.
    Date Received
    November 26, 1979
    Decision Date
    January 4, 1980
    Product Code
    GYE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GYE Encephalogram Telemetry System

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