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    K Number
    K031084
    Device Name
    SOLAR GI SYSTEM
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2004-03-19

    (350 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 :

    SOLAR GI SYSTEM

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

    The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Solar GI". It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), or training set information.

    Therefore, I cannot provide the requested information based on the input text. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

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