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510(k) Data Aggregation

    K Number
    K993269
    Device Name
    IQ NASAL MASK, MODEL P/N 50160
    Manufacturer
    SLEEPNET CORPORATION
    Date Cleared
    1999-10-27

    (27 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 P/N 50160

    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 cmH₂O for the treatment of adult obstructive sleep apnea.

    Device Description

    SleepNet IQ ™ Nasal Mask

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the SleepNet IQ™ Nasal Mask. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. The letter only confirms that the device has been found substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study proving the device meets them based on the given input.

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