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510(k) Data Aggregation
K Number
K973466Device Name
HANAULUX BLUE 75 AND HANAULUX BLUE 120
Manufacturer
HERAEUS MED GMBH
Date Cleared
1997-10-24
(70 days)
Product Code
FSY
Regulation Number
878.4580Why 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
K970886Device Name
HANAULUX BLUE 80 HOSPITAL
Manufacturer
HERAEUS MED GMBH
Date Cleared
1997-04-16
(69 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K954169Device Name
HANAULUX BLUE 30 & 80
Manufacturer
HERAEUS MED GMBH
Date Cleared
1996-02-01
(149 days)
Product Code
FSY
Regulation Number
878.4580Why 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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