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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tonometer, manual
Regulation Description Tonometer and accessories.
Product CodeHKY
Regulation Number 886.1930
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUTOME, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 2
KEELER LIMITED
  SUBSTANTIALLY EQUIVALENT 2
KEELER LTD.
  SUBSTANTIALLY EQUIVALENT 1
SENSOR MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
TAKAGI SEIKO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Difficult to Insert 1
Loose or Intermittent Connection 1
Naturally Worn 1
Device Reprocessing Problem 1
Device Operates Differently Than Expected 1
Contamination / decontamination Problem 1
Total Device Problems 6

Recalls
Manufacturer Recall Class Date Posted
1 Instrumed International, Inc. II Dec-16-2014

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