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510(k) Data Aggregation

    K Number
    K222443
    Device Name
    Air Smart Extra Spirometer
    Manufacturer
    FeelLife Health Inc.
    Date Cleared
    2023-08-09

    (362 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Air Smart Extra Spirometer

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

    The spirometer (Air Smart Extra) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a spirometer. It confirms the device's substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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