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    K Number
    K140951
    Device Name
    YEESCOPE LARYNGOSCOPES
    Manufacturer
    YEESCOPE PTY. LTD.
    Date Cleared
    2014-11-10

    (210 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K062523
    Why did this record match?
    Applicant Name (Manufacturer) :

    YEESCOPE PTY. LTD.

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

    The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended 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

    Yeescope laryngoscope blades and handles are single use, fully disposable laryngoscopes identical to our standard units except we have exchanged the battery to one that is less magnetic and thus would meet the requirements for MR conditional environments.

    Yeescope laryngoscope are offered in one (1) style and two (2) sizes; Macintosh style (curved) and in Sizes 3 and 4.

    AI/ML Overview

    The Yeescope Laryngoscope is a single use, disposable laryngoscope blade and handle intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment up to a 3.0 Tesla static magnetic field.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (from ASTM F2052-02)Reported Device Performance
    Deflection of
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