BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AP-CHECK

    K Number: K830877 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    13
    Review Days
    82

    Basic Information

    Device Name
    AP-CHECK
    K Number
    K830877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1410
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    GENERAL DEVICES
    Date Received
    March 18, 1983
    Decision Date
    June 8, 1983
    Product Code
    GYA
    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
    GYA Tester, Electrode/Lead, Electroencephalograph

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