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

    MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE

    K Number: K945102 · Decision Nov 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    25
    Applicant Total
    10
    Review Days
    17

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    Basic Information

    Device Name
    MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE
    K Number
    K945102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alm Surgical Equipment, Inc.
    Date Received
    October 18, 1994
    Decision Date
    November 4, 1994
    Product Code
    FFS
    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
    FFS Image, Illumination, Fiberoptic, For Endoscope

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