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510(k) Data Aggregation

    K Number
    K062478
    Device Name
    CLAVIS
    Manufacturer
    MEDTRONIC A/S
    Date Cleared
    2007-02-08

    (168 days)

    Product Code
    BXN,GWL
    Regulation Number
    868.2775
    Type
    Abbreviated
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC A/S

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

    CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

    Device Description

    CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for the Clavis EMG device. It establishes substantial equivalence but does not contain detailed information about acceptance criteria, study methodologies, or specific performance metrics. Therefore, I cannot extract the requested information from this document.

    To answer your questions, I would need access to the actual 510(k) submission summary or the associated clinical trial data, which is not present in the provided text.

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