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

    MODEL 700 GASTROREFLUX MONITOR/AMALYZER

    K Number: K822815 · Decision Oct 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    54
    Review Days
    32

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    Basic Information

    Device Name
    MODEL 700 GASTROREFLUX MONITOR/AMALYZER
    K Number
    K822815
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Del Mar Avionics
    Date Received
    September 20, 1982
    Decision Date
    October 22, 1982
    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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