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510(k) Data Aggregation

    K Number
    K121378
    Device Name
    AIRTRAQ SP AIRTRAQ AVANT
    Manufacturer
    PRODOL MEDITEC LTD.
    Date Cleared
    2012-06-21

    (44 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRODOL MEDITEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airtraq® SP - MR and Airtraq® Avant are 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
    Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models. Airtraq® SP - single patient This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable. Airtraq® Avant Avant once assembled is identical in its design and function as the Airtraq@ SP model. Avant is designed as 2 components unlike the Airtraq® SP model. 1. Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery. 2. Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.
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