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510(k) Data Aggregation

    K Number
    K973466
    Device Name
    HANAULUX BLUE 75 AND HANAULUX BLUE 120
    Manufacturer
    HERAEUS MED GMBH
    Date Cleared
    1997-10-24

    (70 days)

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

    HERAEUS MED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hanaulux blue 75 / 120 are surgical luminaires used in the patient area and intended to illuminate locally the body of the patient. They are installed as a system of one, two or three luminaires and are intended to support the treatment and diagnosis. They are intended to be used in operating rooms and not for direct contact with patient.
    Device Description
    Hanaulux blue 75 / 120 is an Examination and Surgical Light with two lighthead combinations of blue 75 and blue 120. The Hanaulux® blue 75 / 120 is principally the same as the Hanaulux(") blue 30 / 80 in design, material and function. They are intended for illumination purpose and are not intended for therapeutic use and direct contact with the patient. All used plastics are molded of UL Recognized Component material. All internal wiring is either Listed fixture wire or Recognized Component appliance wiring material. The maximum of UV Irradiance is lower then 6 W / m² . Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code. The system is intended to be connected to a remote, listed, isolating type, 24V transformer.
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    K Number
    K970886
    Device Name
    HANAULUX BLUE 80 HOSPITAL
    Manufacturer
    HERAEUS MED GMBH
    Date Cleared
    1997-04-16

    (69 days)

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

    HERAEUS MED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light.
    Device Description
    Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.
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    K Number
    K954169
    Device Name
    HANAULUX BLUE 30 & 80
    Manufacturer
    HERAEUS MED GMBH
    Date Cleared
    1996-02-01

    (149 days)

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

    HERAEUS MED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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