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510(k) Data Aggregation

    K Number
    K982408
    Device Name
    AEROTEE, MODEL # 1001
    Manufacturer
    PIPER MEDICAL PRODUCTS
    Date Cleared
    1998-09-14

    (66 days)

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

    For use with pneumatic small volume nebulizers to deliver aerosolized medication.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the AeroTee device, which confirms its substantial equivalence to legally marketed predicate devices. It does not contain details about performance studies, statistical analyses, or the metrics you've requested.

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