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

    DERMTRODE

    K Number: K883869 · Decision Sep 30, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    DERMTRODE
    K Number
    K883869
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1410
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    World Precision Instruments, Inc.
    Date Received
    September 13, 1988
    Decision Date
    September 30, 1988
    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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