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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultrasound imaging for vascular access for hemodialysis
Regulation Description Ultrasonic pulsed echo imaging system.
Definition Ultrasound imaging for vascular access for hemodialysis
Product CodeSGH
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
X9, INC.
  SUBSTANTIALLY EQUIVALENT 1

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