BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EPHAR

    K Number: K843214 · Decision Nov 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    EPHAR
    K Number
    K843214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Akron City Hospital
    Date Received
    August 15, 1984
    Decision Date
    November 29, 1984
    Product Code
    FFI
    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
    FFI System, Alarm, Electrosurgical

    Other Clearances by Akron City Hospital

    K Number Device Name
    K853280 FOUR CHANNEL PH PROBE