BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    BRAVO PH MONITORING SYSTEM AND ACCESSORIES

    K Number: K102543 · Decision Dec 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    30
    Review Days
    89

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    Basic Information

    Device Name
    BRAVO PH MONITORING SYSTEM AND ACCESSORIES
    K Number
    K102543
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging , Ltd.
    Date Received
    September 3, 2010
    Decision Date
    December 1, 2010
    Product Code
    FFT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FFT Electrode, Ph, Stomach

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