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

    AXCEL SURGICAL LIGHT

    K Number: K030906 · Decision Apr 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    AXCEL SURGICAL LIGHT
    K Number
    K030906
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alm
    Date Received
    March 24, 2003
    Decision Date
    April 23, 2003
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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