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510(k) Data Aggregation

    K Number
    K012939
    Device Name
    AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Date Cleared
    2001-09-28

    (28 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Collapsible Holding Chamber used as an accessory to administer meter dose inhalers to patients being mechanically ventilated.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter for a medical device (AeroVent II™ CHC Collapsible Holding Chamber), not a study report. It does not contain information about acceptance criteria, device performance, study design, or expert ground truth as requested in your prompt. This document primarily states that the device has been found substantially equivalent to legally marketed predicate devices for its stated indications for use.

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