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510(k) Data Aggregation

    K Number
    K071689
    Device Name
    DEVILBISS INTELLIPAP MODEL DV 5 SERIES
    Manufacturer
    SUNRISE MEDICAL
    Date Cleared
    2007-09-07

    (79 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K091919,K093070,K112220,K143677
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DeVilbiss IntelliPAP Model DV5 Series is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the DeVilbiss IntelliPAP Model DV5 Series. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device for treating obstructive sleep apnea.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) from the provided text.

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