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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic video imaging system / software component for real time video augmentation
Regulation Description Endoscope and accessories.
Definition To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
Product CodeSFE
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
HYPERVISION SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

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