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510(k) Data Aggregation
K Number
K120392Device Name
CHROMOPHARE F 628 AND F 528
Manufacturer
BERCHTOLD GMBH & CO. KG
Date Cleared
2012-02-16
(8 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
**BERCHTOLD GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The surgical lights BERCHTOLD CHROMOPHARE® F 628 and F 528 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Device Description
The new BERCHTOLD CHROMOPHARE® F 628 and F 528 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in combination with reflector technology, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated in-light video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other or with other CHROMOPHARE devices, on ceiling mounted, wall mounted and floorstand configurations.
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K Number
K090378Device Name
CHROMOPHARE E 668
Manufacturer
BERCHTOLD GMBH & CO. KG
Date Cleared
2009-02-23
(6 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
**BERCHTOLD GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 668 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Device Description
The new BERCHTOLD CHROMOPHARE® E 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
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