TPLC - Total Product Life Cycle

Device	transmitters and receivers, electrocardiograph, telephone
Regulation Description	Telephone electrocardiograph transmitter and receiver.
Product Code	DXH
Regulation Number	870.2920
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALARIS MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANALOGIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
	SUBSTANTIALLY EQUIVALENT	28
CORSCIENCE GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
DATA CRITICAL
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC DEVICES PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	2
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	4
INSTROMEDIX
	SUBSTANTIALLY EQUIVALENT	1
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	5
IRHYTHM TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DATA ELECTRONICS
	SUBSTANTIALLY EQUIVALENT	4
MEDICAL MONITORS LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	15
NIHON KOHDEN CORP.
	SUBSTANTIALLY EQUIVALENT	1
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	5
PINMED, INC
	SUBSTANTIALLY EQUIVALENT	1
PROTEUS
	SUBSTANTIALLY EQUIVALENT	1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	3
ROZINN ELECTRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SCOTTCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHL TELEMEDICINE INTERNATIONAL LTD.
	SUBSTANTIALLY EQUIVALENT	3
SIGNALIFE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELOVITAL GMBH TELEMEDIZIN
	SUBSTANTIALLY EQUIVALENT	1
TZ MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
UNIVERSAL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	8
VITASYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1