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510(k) Data Aggregation

    K Number
    K964130
    Device Name
    AEROGEAR ASTHMA ACTION KIT
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Date Cleared
    1997-01-10

    (87 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The AeroGear Asthma Action Kit is a product containing the AeroChamber Aerosol Holding Chamber, a TruZone Peak Flow Meter, and educational materials used in an asthma management program. This kit is intended to be marketed to hospitals, outpatient clinics and physicians.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

    The document is a 510(k) summary for a medical device (AeroGear Asthma Action Kit) submitted in 1997. It describes the device, its components (which are previously cleared devices), and its intended marketing audience. It does not include any performance data or a study design.

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