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510(k) Data Aggregation

    K Number
    K050309
    Device Name
    PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2005-03-25

    (45 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000

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

    The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the PULMANEX® Disposable Pressure Manometer. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert ground truth establishment, or AI-related details. The letter confirms substantial equivalence to a predicate device but does not detail the testing or validation studies performed.

    Therefore, I cannot provide the requested information based on the input text.

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