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

    ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES

    K Number: K982965 · Decision Nov 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    142
    Review Days
    90

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    Basic Information

    Device Name
    ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
    K Number
    K982965
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    August 25, 1998
    Decision Date
    November 23, 1998
    Product Code
    FWF
    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
    FWF Camera, Television, Endoscopic, Without Audio

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