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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device amplifier and signal conditioner, transducer signal
Regulation Description Transducer signal amplifier and conditioner.
Product CodeDRQ
Regulation Number 870.2060
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Operates Differently Than Expected 3
Amplifier 1
Electrical Power Problem 1
Total Device Problems 5

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jun-18-2015

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