BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HANAULUX 2005 SURGICAL LIGHT

    K Number: K932451 · Decision Nov 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    28
    Applicant Total
    1
    Review Days
    176

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    Basic Information

    Device Name
    HANAULUX 2005 SURGICAL LIGHT
    K Number
    K932451
    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
    Heraeus Instruments GmbH
    Date Received
    May 20, 1993
    Decision Date
    November 12, 1993
    Product Code
    FTD
    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
    FTD Lamp, Surgical

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