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

    ISOLATED CAMERA HEAD

    K Number: K944707 · Decision Oct 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    ISOLATED CAMERA HEAD
    K Number
    K944707
    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
    Envision Medical Corp.
    Date Received
    September 23, 1994
    Decision Date
    October 7, 1994
    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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    Other Clearances by Envision Medical Corp.

    K Number Device Name
    K970605 3-CCD DIGITAL CAMERA
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    K934092 CAMERA, SURGICAL AND ACCESSORIES