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

    BIRTCHER UV LAMP

    K Number: K973865 · Decision Feb 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    508

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    Basic Information

    Device Name
    BIRTCHER UV LAMP
    K Number
    K973865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medfaxx, Inc.
    Date Received
    October 6, 1997
    Decision Date
    February 26, 1999
    Product Code
    MXG
    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
    MXG Lamp, Uvc, (For Treating Skin And Wounds)