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

    LUMINOUS 150 FIBEROPTIC ILLUMINATOR

    K Number: K933593 · Decision Oct 28, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    27
    Applicant Total
    7
    Review Days
    94

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    Basic Information

    Device Name
    LUMINOUS 150 FIBEROPTIC ILLUMINATOR
    K Number
    K933593
    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
    Progressive Dynamics, Inc.
    Date Received
    July 26, 1993
    Decision Date
    October 28, 1993
    Product Code
    HBI
    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
    HBI Illuminator, Fiberoptic, Surgical Field

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    Other Clearances by Progressive Dynamics, Inc.

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    K921866 LUMINOUS 250 FIBEROPTIC ILLUMINATOR
    K914382 LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM
    K914383 LIFE-AIR 1000 PATIENT WARMING COVERS