TPLC - Total Product Life Cycle

• 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
BIO-MED
	SUBSTANTIALLY EQUIVALENT	1
DATASCOPE CORP.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
GAMBRO
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	3
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORP.
	SUBSTANTIALLY EQUIVALENT	1
NOVAMETRIX
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SALTER LABS
	SUBSTANTIALLY EQUIVALENT	4
SIEMENS
	SUBSTANTIALLY EQUIVALENT	2
THORATEC CORP.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR TECHNOLOGY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4

Device Problems
Device inoperable	2
Failure to deliver	2
Device displays error message	2
Calibration issue	1
Total Device Problems	7

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	0	0	0	0	0	0	0	0	0	0	0
Class II	0	0	1	0	0	0	0	2	1	0	0
Class III	0	0	0	0	0	0	0	0	0	0	0

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
4	Teleflex Medical	II	Dec-29-2009