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510(k) Data Aggregation

    K Number
    K092292
    Device Name
    CHECKPOINT
    Manufacturer
    NDI MEDICAL LLC
    Date Cleared
    2009-10-28

    (91 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDI MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability. The Checkpoint is available for prescription use only.
    Device Description
    The Checkpoint® is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.
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