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

    OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

    K Number: K981993 · Decision Aug 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    17
    Applicant Total
    22
    Review Days
    74

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    Basic Information

    Device Name
    OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
    K Number
    K981993
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Olympus Optical Co.
    Date Received
    June 8, 1998
    Decision Date
    August 21, 1998
    Product Code
    ODA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODA Endoscopic Central Control Unit

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