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510(k) Data Aggregation
K Number
K132551Device Name
ZF 720
Manufacturer
UMBEL CORPORATION
Date Cleared
2014-06-30
(320 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
UMBEL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.
Device Description
The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedures. With ceiling, wall and floor versions, the Surgical Light ZF 720 Systems are well-suited for various operating rooms. The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment. The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions. With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.
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