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510(k) Data Aggregation

    K Number
    K022650
    Device Name
    APEX MEDICAL CPAP RT 21XX
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2004-02-04

    (544 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K083656
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a CPAP device. This document does not contain information regarding acceptance criteria, device performance, study methodologies (such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance), or details about ground truth establishment for any machine learning or AI models.

    Therefore, I cannot fulfill your request for this information based on the input document.

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