TPLC - Total Product Life Cycle

• Device: electrocardiograph
• Regulation Description: Electrocardiograph.
• Product Code: DPS
• Regulation Number: 870.2340
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
AGILENT TECHNIOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
ANALOGIC CORP.
	SUBSTANTIALLY EQUIVALENT	3
ANDON HEALTH CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BELMONT INSTRUMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	2
BIOTRONIK GMBG & CO.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
CAMBRIDGE HEART, INC.
	SUBSTANTIALLY EQUIVALENT	8
CARDIAC SCIENCE CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
COMMWELL LTD.
	SUBSTANTIALLY EQUIVALENT	2
COMPUTERIZED MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
DAILYCARE BIOMEDICAL INC
	SUBSTANTIALLY EQUIVALENT	4
DATA CRITICAL
	SUBSTANTIALLY EQUIVALENT	1
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DYANSYS CORP
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	6
ELMED
	SUBSTANTIALLY EQUIVALENT	1
ENERGY-LAB TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	1
ET MEDICAL DEVICES SPA
	SUBSTANTIALLY EQUIVALENT	2
FUKUDA DENSHI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	6
GRAHAM-FIELD HEALTH PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEARTSCAPE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	14
INOVISE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
INTELWAVE, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	4
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MARQUETTE
	SUBSTANTIALLY EQUIVALENT	10
MEDICAL DATA ELECTRONICS
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL POSITIONING, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDICAL PREDICTIVE SCIENCE CORP.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
MONEBO TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MORTARA
	SUBSTANTIALLY EQUIVALENT	17
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT	2
NIHON KOHDEN CORP.
	SUBSTANTIALLY EQUIVALENT	21
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PARAMA-TECH COMPANY., LTD
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	8
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	5
QRS
	SUBSTANTIALLY EQUIVALENT	1
S & W MEDICO TEKNIK
	SUBSTANTIALLY EQUIVALENT	3
SCHILLER
	SUBSTANTIALLY EQUIVALENT	6
SHL TELEMEDICINE INTERNATIONAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS
	SUBSTANTIALLY EQUIVALENT	3
SUZUKEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TELOVITAL GMBH TELEMEDIZIN
	SUBSTANTIALLY EQUIVALENT	1
VIASYS HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
VICOR TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No code available	65
Data Issue	9
Artifact	8
Failure to power-up	7
Loss of Data	7
Application program issue	4
Communication or transmission issue	3
Device displays error message	3
Computer software issue	3
Patient Data Issue	3
Failure to transmit record	2
Incorrect display	2
Device inoperable	1
No display or display failure	1
Total Device Problems	118

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	0	2	2	1	0
Class III	1	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	AGFA Corp.	II	Jul-29-2010
2	Del Mar Reynolds Medical, Ltd.	II	Jan-13-2012
3	Edan Instruments, Inc.	II	Oct-12-2011
4	GE Medical Systems, LLC	II	Jan-21-2010
5	Medtronic Inc. Cardiac Rhythm Managment	III	Nov-06-2007
6	Philips Healthcare Inc.	II	Jun-17-2011
7	Philips Medical Systems	II	Jan-30-2008