• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
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

-
-