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

    WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

    K Number: K945877 · Decision Mar 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    15
    Review Days
    91

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    Basic Information

    Device Name
    WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT
    K Number
    K945877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1945
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wells Johnson Co.
    Date Received
    December 1, 1994
    Decision Date
    March 2, 1995
    Product Code
    HJM
    Advisory Committee
    Ophthalmic
    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
    HJM Transilluminator, Ac-Powered

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