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    K Number
    K082209
    Device Name
    DEVILBISS DV5M SMARTLINK SYSTEM
    Manufacturer
    SUNRISE MEDICAL
    Date Cleared
    2008-10-28

    (84 days)

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

    DEVILBISS DV5M SMARTLINK SYSTEM

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

    The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "DeVilbiss DV5M Smartlink System." This document grants market clearance based on substantial equivalence to a predicate device and does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

    To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification of the device and its validation.

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