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

    AD-TECH'S FORAMEN OVALE ELECTRODE

    K Number: K990788 · Decision Nov 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    18
    Review Days
    237

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    Basic Information

    Device Name
    AD-TECH'S FORAMEN OVALE ELECTRODE
    K Number
    K990788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ad-Tech Medical Instrument Corp
    Date Received
    March 10, 1999
    Decision Date
    November 2, 1999
    Product Code
    GZL
    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
    GZL Electrode, Depth

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    Other Clearances by Ad-Tech Medical Instrument Corp

    K Number Device Name
    K112094 BRAIN BIOPSY NEEDLE
    K053363 DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
    K053358 DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
    K041604 MACRO-MICRO DEPTH ELECTRODE
    K992194 CORTICAL MAPPING UNIT, MODEL CMU
    K973454 AD-TECH'S SPINAL ELECTRODE
    K970587 AD-TECH SUBDURAL ELECTRODE
    K964644 AD-TECH'S DEPTH ELECTRODE
    K940320 AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
    K944061 CUEVA CRANIAL NERVE ELECTRODE
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