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510(k) Data Aggregation

    K Number
    K982530
    Device Name
    SULLIVAN MIRAGE FULL FACE MASK
    Manufacturer
    RESMED LTD.
    Date Cleared
    1998-10-16

    (88 days)

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

    SULLIVAN MIRAGE FULL FACE MASK

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

    The Sullivan® Mirage™ Full Face Mask is a patient interface accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.

    Device Description

    Sullivan® Mirage™ Full Face Mask System

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Sullivan® Mirage™ Full Face Mask System). This document does not contain any information regarding acceptance criteria, study details, or performance metrics for the device.

    Therefore, I cannot provide the requested table and information about a study based on this input. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

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