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510(k) Data Aggregation

    K Number
    K150515
    Device Name
    IQSense Flow Sensor Mouthpiece
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2016-01-12

    (316 days)

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

    IQSense Flow Sensor Mouthpiece

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

    The IQSense Flow Sensor Mouthpiece is intended to be used as a disposable pneumotach mouthpiece for the Midmark (formerly Brentwood) IQspiro Digital Spirometer.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K150515 for the "IOSense Flow Sensor Mouthpiece" is a clearance letter and an "Indications for Use" statement. It does not contain information about the acceptance criteria, study details, or performance data of the device.

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

    To answer your request, I would need a document such as the 510(k) summary or the full 510(k) submission, which typically includes detailed study reports and performance data.

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