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

    VITLITE (TR7700)

    K Number: K963417 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    3
    Review Days
    112

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    Basic Information

    Device Name
    VITLITE (TR7700)
    K Number
    K963417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Escalon Trek Medical
    Date Received
    August 30, 1996
    Decision Date
    December 20, 1996
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPA Endoilluminator

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    Other Clearances by Escalon Trek Medical

    K Number Device Name
    K963434 VISCOUS FLUID SYSTEM
    K924999 AUTOPOLE REGULATOR SYSTEM