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510(k) Data Aggregation

    K Number
    K042595
    Device Name
    SPIRO'AIR
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2005-05-04

    (223 days)

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

    SPIRO'AIR

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

    The SpiroAir PFT System is intended to operate with the ComPAS pulmonary function software. ComPAS uses flow and volume from the SpiroAir to display the flow and volume information and to generate reports. ComPAS utilizes gas analysis from the SpiroAir to display single breath diffusion data and to generate reports.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the SpiroAir PFT System, a diagnostic spirometer. It does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt.

    The letter primarily:

    • Confirms the device's substantial equivalence to a predicate device.
    • Outlines general regulatory requirements.
    • States the indications for use.

    Therefore, I cannot provide the requested information from the provided text. The document is administrative, not a technical report detailing performance studies.

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