LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070609
    Device Name
    APEX MEDICAL XT1 CPAP, MODEL 9S-005
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2007-05-04

    (60 days)

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

    APEX MEDICAL XT1 CPAP, MODEL 9S-005

    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

    This document is a 510(k) premarket notification letter from the FDA to Apex Medical Corporation for their XT1 CPAP Model 9S-005 device. It confirms that the device is substantially equivalent to legally marketed predicate devices for the treatment of adult obstructive sleep apnea (OSA).

    However, the provided text does not contain specific information about:

    • Acceptance criteria and reported device performance (in a table format or otherwise)
    • Sample size used for a test set, its provenance, or how ground truth was established for it
    • Number of experts or their qualifications for ground truth establishment
    • Adjudication methods
    • Multi-reader multi-case (MRMC) comparative effectiveness studies
    • Standalone algorithm performance studies
    • Sample size for the training set or how its ground truth was established

    The document is a regulatory approval notice, not a clinical study report or a technical performance evaluation. Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1