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510(k) Data Aggregation

    K Number
    K992192
    Device Name
    AIRPILOTMASK, MODEL TMS-900
    Manufacturer
    TIARA MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-05-12

    (318 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AIRPILOTMASK, MODEL TMS-900

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

    The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous airway pressure) devices for the treatment of adult obstructive sleep apnea.

    Device Description

    TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask

    AI/ML Overview

    The provided text pertains to an FDA 510(k) clearance letter for a medical device called "AirPilotMask, Model TMS-900." This document does not contain information about acceptance criteria, the study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for that information based solely on the provided text. The document is an administrative letter indicating that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not detail the technical performance studies or criteria used to make that determination.

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