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510(k) Data Aggregation

    K Number
    K973456
    Device Name
    SPIROBANK PORTABLE PC BASED SPIROMETER
    Manufacturer
    FUTUREMED AMERICA, INC.
    Date Cleared
    1998-07-22

    (314 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations.

    The tests can be performed in adults and pediatrics, in the hospital, clinic and at home.

    Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "SPIROBANK" Portable PC Based Spirometer. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the letter does not contain any information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study details (MRMC or standalone).

    Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval, not a technical study report.

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