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510(k) Data Aggregation

    K Number
    K990098

    Validate with FDA (Live)

    Device Name
    VENTLAB VERIFY II
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    1999-02-11

    (30 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ventlab Verify II is designed to assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation and does not eliminate clinical judgment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and study details for the Ventlab Verify II device. The document is an FDA 510(k) clearance letter, confirming the device's substantial equivalence to a predicate device, but it does not include performance data, study design, sample sizes, or ground truth establishment.

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