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

    XENON 300MX

    K Number: K980044 · Decision Apr 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    XENON 300MX
    K Number
    K980044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perkinelmer Optoelectronics
    Date Received
    January 6, 1998
    Decision Date
    April 3, 1998
    Product Code
    FSS
    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
    FSS Light, Surgical, Floor Standing

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    Other Clearances by Perkinelmer Optoelectronics

    K Number Device Name
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