TPLC - Total Product Life Cycle

Device	cable, transducer and electrode, patient, (including connector)
Regulation Description	Patient transducer and electrode cable (including connector).
Product Code	DSA
Regulation Number	870.2900
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ACIST MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN I.V. PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOSENSE
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONMED
	SUBSTANTIALLY EQUIVALENT	2
CURBELL ELECTRONICS INC.
	SUBSTANTIALLY EQUIVALENT	2
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAG CORP.
	SUBSTANTIALLY EQUIVALENT	1
EUROPEAN CUSTOM MANUFACTURING BV
	SUBSTANTIALLY EQUIVALENT	1
EWC
	SUBSTANTIALLY EQUIVALENT	2
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	1
LIFESYNC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MED-DYNE
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	5
MINNESOTA MINING AND MFG. CO.
	SUBSTANTIALLY EQUIVALENT	1
PACE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
Remington Medical, Inc.
	SUBSTANTIALLY EQUIVALENT	2
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
TZ MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIMED
	SUBSTANTIALLY EQUIVALENT	1
VANGUARD MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
High impedance	3
Incorrect or inadequate result	3
Unstable	2
No Known Device Problem	1
Incorrect measurement	1
Total Device Problems	10