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

    ISO-100 ISOLATION AMPLIFIER

    K Number: K883947 · Decision Dec 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    14
    Review Days
    77

    Basic Information

    Device Name
    ISO-100 ISOLATION AMPLIFIER
    K Number
    K883947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    TELEDIAGNOSTIC SYSTEMS, INC.
    Date Received
    September 19, 1988
    Decision Date
    December 5, 1988
    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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