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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device esophageal, mucosal, electrical characterization
Definition The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Product CodeQIS
Regulation Number 876.1450
Device Class 2


Premarket Reviews
ManufacturerDecision
DIVERSATEK HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
DIVERSATEK HEALTHCARE INC.
  GRANTED 1

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