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

    NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM

    K Number: K060717 · Decision Apr 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    39

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    Basic Information

    Device Name
    NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
    K Number
    K060717
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conmed Integrated Systems (Cmis)
    Date Received
    March 17, 2006
    Decision Date
    April 25, 2006
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Conmed Integrated Systems (Cmis)

    K Number Device Name
    K091648 NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
    K052740 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
    K050829 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
    K031979 CONMED INTEGRATED SYSTEMS NURSES ASSISTANT