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510(k) Data Aggregation

    K Number
    K130513
    Device Name
    VOLISTA 400; VOLISTA 600
    Manufacturer
    MAQUET SAS
    Date Cleared
    2013-05-08

    (70 days)

    Product Code
    FTD, FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAQUET SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
    Device Description
    MAQUET TRIOP VOLISTA® Surgical Light Systems have been developed in order to provide any operating room with LED technology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. The TRIOP VOLISTA® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations. The TRIOP VOLISTA® product family is composed by two different lightheads, Volista 400 and Volista 600. The System is available on ceiling versions and may be composed by one, two or three lightheads, which can be every possible combination of VOLISTA 400 and VOLISTA 600. Accessories such as integrated cameras and screen supports can be included to the TRIOP VOLISTA® Surgical Light System.
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    K Number
    K113679
    Device Name
    LUCEA LED SURGICAL LIGHT SYSTEM
    Manufacturer
    MAQUET SAS
    Date Cleared
    2012-01-12

    (29 days)

    Product Code
    NTN, FSS, FTD
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAQUET SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
    Device Description
    MAQUET LUCEA LED® Surgical Light Systems have been developed in order to provide MAQUET EUGEAEED Surgied Lightnology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights. The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.
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