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510(k) Data Aggregation

    K Number
    K013752
    Device Name
    COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2002-01-30

    (78 days)

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

    COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)

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

    The ComPAS software is intended to operate with the ScreenStar pneumotachograph The Oomr AS sonward to intended to tpon the ScreenStar to display the flow and volume spiromotor: Gomi FD doo hy from patient effort. This information is formatted for use in pulmonary function testing and reports.

    Device Description

    ComPAS (computerized Pulmonary Analysis Sysem)

    AI/ML Overview

    I am sorry, but based on the provided text, the document is a 510(k) clearance letter for the ComPAS (computerized Pulmonary Analysis System) software. It affirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain the detailed study information such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any information about a multi-reader multi-case study, or standalone performance. The letter refers to indications for use but does not delve into the specifics of the testing methodology or results.

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