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    K Number
    K063477
    Device Name
    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
    Manufacturer
    NOVAMED, LLC
    Date Cleared
    2007-02-09

    (85 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K041852
    Why did this record match?
    Device Name :

    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

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

    The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

    Device Description

    The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

    AI/ML Overview

    The NovaMed MRI Conditional Laryngoscope set was evaluated for safety in a Magnetic Resonance (MR) environment up to 3.0 Tesla. The primary study was to determine the device's magnetic attraction in this environment.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
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