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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device counter (beta, gamma) for clinical use
Regulation Description Beta or gamma counter for clinical use.
Product CodeJJJ
Regulation Number 862.2320
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Pressure issue 1
Total Device Problems 1

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