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510(k) K250462

UL UHD-Clear View 4K Camera System (UL-3Chip 4K) by Univlabs Technologies Private Limited — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2025
Date Received
February 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

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