LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053325
    Device Name
    MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001
    Manufacturer
    MEDIWATCH LTD
    Date Cleared
    2005-12-07

    (6 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIWATCH LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ (Testes), Transrectal.
    Device Description
    Mediwatch Multiscan Ultrasound System / Scanner
    Ask a Question

    Page 1 of 1