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

    ORS MODEL 6000 ENDOSCOPE HOLDER

    K Number: K051979 · Decision Aug 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    ORS MODEL 6000 ENDOSCOPE HOLDER
    K Number
    K051979
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O.R. Solutions, Inc.
    Date Received
    July 21, 2005
    Decision Date
    August 30, 2005
    Product Code
    OCT
    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
    OCT Anti Fog Solution And Accessories, Endoscopy

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    Other Clearances by O.R. Solutions, Inc.

    K Number Device Name
    K023282 ORS-3000LD
    K023283 1075LD HUSH-SLUSH
    K021288 ORS-1000LD
    K021289 WARMER 2000LD
    K960836 DMS-9000
    K953654 ORS-111