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    K Number
    K112435
    Device Name
    RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
    Manufacturer
    RHYTHMLINK INTERNATIONAL, LLC
    Date Cleared
    2011-09-22

    (29 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Type
    Special
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K072736
    Why did this record match?
    Device Name :

    RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only

    Device Description

    Monopolar Stimulating Instrument

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a Monopolar Stimulating Instrument. It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    However, it does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. Therefore, I am unable to fulfill your request based on the provided input.

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