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

    BRIGHTSTAR

    K Number: K981081 · Decision Apr 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    33
    Review Days
    36

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    Basic Information

    Device Name
    BRIGHTSTAR
    K Number
    K981081
    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
    Hill-Rom, Inc.
    Date Received
    March 24, 1998
    Decision Date
    April 29, 1998
    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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