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

    ESA CAMERA

    K Number: K823516 · Decision Dec 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    83
    Review Days
    31

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    Basic Information

    Device Name
    ESA CAMERA
    K Number
    K823516
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Concept, Inc.
    Date Received
    November 29, 1982
    Decision Date
    December 30, 1982
    Product Code
    FWH
    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
    FWH Camera, Cine, Surgical, Without Audio

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