BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 1010 AMBULATORY PH MONITORING SYSTEM

    K Number: K862536 · Decision Sep 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    48
    Review Days
    72

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    Basic Information

    Device Name
    MODEL 1010 AMBULATORY PH MONITORING SYSTEM
    K Number
    K862536
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Oxford Medilog, Inc.
    Date Received
    July 2, 1986
    Decision Date
    September 12, 1986
    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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