LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K042384
    Device Name
    NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
    Manufacturer
    CYBERKINETICS, INC. (CKI)
    Date Cleared
    2005-03-29

    (209 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYBERKINETICS, INC. (CKI)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (<30 days) recording and monitoring of brain electrical activity.
    Device Description
    The NeuroPort™ Array System (Neuroport Electrode) is comprised of a base approximately 4 mm x 4 mm dimensionally with 100 microelectrodes. Each microelectrode is approximately 1 mm long. The lead connects the microelectrode array to the percutaneous pedestal connector.
    Ask a Question

    Page 1 of 1