LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980971
    Device Name
    BODYSTAT DUALSCAN 2005
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    1998-06-11

    (87 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BODYSTAT DUALSCAN 2005

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

    ESTIMATED MEASUREMENT OF: FAT, LEAN, WATER, INTRA-CELLULAR WATER, EXTRA-CELLULAR WATER, TOTAL ESTIMATED WATER AND IMPEDANCE VALUES AT 50 KHZ

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Bodystat® LTD. DuelScan 2005 Dual-Frequency Monitoring Unit). This document primarily focuses on regulatory approval and the device's substantial equivalence to previously marketed devices.

    It does not contain the detailed information required to answer your questions regarding acceptance criteria, study design, performance results, or ground truth establishment. The letter refers to indications for use but does not provide the specifics of a study proving those indications or device performance against acceptance criteria.

    Therefore, I cannot extract the information required to populate the table and answer the study-related questions based on this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1