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

    NICOLET EPIDURAL SPINAL ELECTRODE

    K Number: K882053 · Decision Oct 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    13
    Review Days
    155

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    Basic Information

    Device Name
    NICOLET EPIDURAL SPINAL ELECTRODE
    K Number
    K882053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Nicolet Instrument Corp.
    Date Received
    May 16, 1988
    Decision Date
    October 18, 1988
    Product Code
    GYC
    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
    GYC Electrode, Cortical

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    Other Clearances by Nicolet Instrument Corp.

    K Number Device Name
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    K905632 NICOLET MAPLELEAF SYSTEM
    K897154 NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
    K894629 NICOLET BEAM II SYSTEM
    K896477 NICOLET REAL EAR ANALYZER
    K883781 NICOLET NEUROPORT/ACE SYSTEM
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