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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, gas, oxygen, gaseous-phase
Regulation Description Oxygen gas analyzer.
Product CodeCCL
Regulation Number 868.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Inoperable 2
Device Displays Incorrect Message 2
Calibration Problem 1
Total Device Problems 5

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II May-28-2015
2 GE Healthcare, LLC II Sep-09-2014
3 GE Healthcare, LLC II Jun-17-2014

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