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

    EVOKED POTENTIAL CAP W/EVOKED POTENTIAL

    K Number: K830598 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    EVOKED POTENTIAL CAP W/EVOKED POTENTIAL
    K Number
    K830598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Precision Cap Systems
    Date Received
    February 24, 1983
    Decision Date
    March 24, 1983
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Precision Cap Systems

    K Number Device Name
    K830600 REFERENCE & MONITORING ELECTRODE
    K830597 BABY CAP, ELECTRODE SET & BOARD ADAPTOR
    K830521 PRECISION EEG CAP W/ELECTRODE SET AND
    K830601 FOAMIES DIAPOS. FOAM RUBBER PADS
    K830602 PRECISION CAP STRAPS
    K830599 LOCALIZING ELECTRODE