BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    3D VIDEO SYSTEM

    K Number: K934883 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    142
    Review Days
    146

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    Basic Information

    Device Name
    3D VIDEO SYSTEM
    K Number
    K934883
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    October 12, 1993
    Decision Date
    March 7, 1994
    Product Code
    FWG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FWG Camera, Television, Endoscopic, With Audio

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