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510(k) Data Aggregation

    K Number
    K021534
    Device Name
    IQ NASAL MASK, MODEL 50160 REV. D
    Manufacturer
    SLEEPNET CORPORATION
    Date Cleared
    2002-07-02

    (53 days)

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

    IQ NASAL MASK, MODEL 50160 REV. D

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

    The SleepNet Corporation IQ® Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). operating at or above 3 cmHzO for the treatment of adult obstructive sleep apnea.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (SleepNet IQ® Nasal Mask).

    This type of document primarily addresses the substantial equivalence of a new device to a legally marketed predicate device. It does not contain details about specific acceptance criteria or the results of a study designed to prove the device meets those criteria.

    Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies from this text. The letter focuses on regulatory approval based on equivalence, not on a detailed performance study report.

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