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    K Number
    K991288
    Device Name
    DISTENDER SERIES II BAROSTAT
    Manufacturer
    G & J ELECTRONICS, INC.
    Date Cleared
    1999-06-08

    (55 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISTENDER SERIES II BAROSTAT

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

    The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of pationts with symptoms consistent with gastrointestinal motility disorders.

    Device Description

    The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Distender Series II Barostat" and its "Indications For Use." It does not contain information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert details.

    Therefore, I cannot provide the requested information. The document serves as a regulatory approval and outlines the intended use of the device but does not detail the technical performance or validation studies.

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