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510(k) Data Aggregation

    K Number
    K140268
    Device Name
    SIMPLE T YOUTH NASAL MASK
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2014-10-20

    (250 days)

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

    SIMPLE T YOUTH NASAL MASK

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

    The Simple T Youth Nasal Mask is intended for use with CPAP or bi-level therapy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the U.S. FDA document is heavily corrupted and contains significant amounts of non-English and garbled characters, particularly in the sections that would typically detail acceptance criteria and study information.

    Due to the severe corruption, I cannot extract the specific information requested regarding the acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods.

    The document appears to be a 510(k) clearance letter for the "Simple T Youth Nasal Mask," but the technical details about its performance studies are unreadable in the provided segments.

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