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

    BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE

    K Number: K960081 · Decision Mar 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    61

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    Basic Information

    Device Name
    BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
    K Number
    K960081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mitsubishi Cable America, Inc.
    Date Received
    January 11, 1996
    Decision Date
    March 12, 1996
    Product Code
    FCQ
    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
    FCQ Light Source, Incandescent, Diagnostic

    Other Clearances by Mitsubishi Cable America, Inc.

    K Number Device Name
    K955717 ENDOSCOPE INTRODUCER KIT
    K936257 ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3