TPLC - Total Product Life Cycle

Device	computer, diagnostic, pre-programmed, single-function
Regulation Description	Single-function, preprogrammed diagnostic computer.
Product Code	DXG
Regulation Number	870.1435
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	4
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	3
CHEETAH MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
DATASCOPE CORP.
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	8
FUKUDA DENSHI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	6
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	1
INTEGRATED MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
MARQUETTE
	SUBSTANTIALLY EQUIVALENT	1
MEDASONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDEX
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DATA ELECTRONICS
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL GRAPHICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
MENNEN MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORP.
	SUBSTANTIALLY EQUIVALENT	3
OMEGA
	SUBSTANTIALLY EQUIVALENT	1
PULSION MEDICAL INC., USA
	SUBSTANTIALLY EQUIVALENT	3
S & W MEDICO TEKNIK
	SUBSTANTIALLY EQUIVALENT	1
VITAL SIGNS, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
WITT BIOMEDICAL CORP
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect or inadequate result	60
Smoking	15
Measurements, inaccurate	6
Unknown (for use when the device problem is not known)	5
Break	4
Low readings	3
Cut in material	2
Incorrect measurement	2
Device remains activated	2
Burn of device or device component	2
False reading from device non-compliance	2
Fire	1
Fluid leak	1
Inflation issue	1
Unstable	1
Blood in tubing	1
Other (for use when an appropriate device code cannot be identified)	1
Circuit Failure	1
Coagulation in device or device ingredient	1
Contamination during use	1
Intermittent continuity	1
False device output	1
Overheating of device or device component	1
Pyrogenic	1
Material perforation	1
Blood pooling	1
Incorrect or inadequate test results	1
Spark	1
Total Device Problems	120