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

    TELEMETRY SYSTEM 315

    K Number: K790144 · Decision Feb 23, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    136
    Review Days
    35

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    Basic Information

    Device Name
    TELEMETRY SYSTEM 315
    K Number
    K790144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    January 19, 1979
    Decision Date
    February 23, 1979
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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