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

    ACULUX, MODEL AX3001, AX3002

    K Number: K001223 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    67

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    Basic Information

    Device Name
    ACULUX, MODEL AX3001, AX3002
    K Number
    K001223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aculux
    Date Received
    April 17, 2000
    Decision Date
    June 23, 2000
    Product Code
    FQP
    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
    FQP Lamp, Operating-Room

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