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

    DIAMOND MEDICAL, INC. MODEL DM 800

    K Number: K874709 · Decision Feb 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    DIAMOND MEDICAL, INC. MODEL DM 800
    K Number
    K874709
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Diamond Medical, Inc.
    Date Received
    November 12, 1987
    Decision Date
    February 8, 1988
    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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    K875369 MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT
    K863298 DIAMOND MEDICAL, INC., MODEL DM 700