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

    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

    K Number: K003222 · Decision Nov 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    13
    Applicant Total
    26
    Review Days
    18

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    Basic Information

    Device Name
    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    K Number
    K003222
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Computer Motion, Inc.
    Date Received
    October 16, 2000
    Decision Date
    November 3, 2000
    Product Code
    GCI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCI Laryngoscope, Endoscope

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    Other Clearances by Computer Motion, Inc.

    K Number Device Name
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    K031382 MODIFICATION TO HERMES O.R. CONTROL CENTER
    K030578 BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
    K030718 SCB COMPUTER MOTION INTERFACE CONTROLLER
    K030240 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    K024294 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    K023095 HERMES OPERATING ROOM CONTROL CENTER
    K022897 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    K021152 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
    Search all 26 clearances from Computer Motion, Inc. →