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

    SIGNAL AVERAGER MODEL 4202

    K Number: K781290 · Decision Sep 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    SIGNAL AVERAGER MODEL 4202
    K Number
    K781290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1845
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Princeton Applied Research Corp.
    Date Received
    July 27, 1978
    Decision Date
    September 15, 1978
    Product Code
    GWK
    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
    GWK Conditioner, Signal, Physiological

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    Other Clearances by Princeton Applied Research Corp.

    K Number Device Name
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