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510(k) Data Aggregation

    K Number
    K063813
    Device Name
    VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2008-03-26

    (460 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA

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

    The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Ventlab End-Tidal CO2 Nasal Cannula. This type of document primarily confirms that a new medical device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed technical study report with performance metrics, acceptance criteria, or ground truth establishment.

    Therefore, the information requested in your prompt regarding acceptance criteria, specific performance data, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided text.

    This document focuses on regulatory approval based on equivalence to a predicate, not on a detailed clinical or technical performance study as would be found in a research paper or a more extensive submission report.

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