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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device system, imaging, tympanic membrane and middle ear
Regulation Description Ultrasonic pulsed echo imaging system.
Definition Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
Product CodeQJG
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
PHOTONICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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