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TPLC
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Device
analyzer, gas, oxygen, gaseous-phase
Regulation Description
Oxygen gas analyzer.
Product Code
CCL
Regulation Number
868.1720
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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