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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocardiograph
Regulation Description Electrocardiograph.
Product CodeDPS
Regulation Number 870.2340
Device Class 2


Premarket Reviews
ManufacturerDecision
  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 10
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 7
GRAHAM-FIELD HEALTH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 18
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 9
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 5
QRS
  SUBSTANTIALLY EQUIVALENT 1
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 3
SCHILLER
  SUBSTANTIALLY EQUIVALENT 7
SHL TELEMEDICINE INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 66
Data Issue 9
Artifact 8
Failure to power-up 7
Loss of Data 7
Patient Data Issue 4
Application program issue 4
Communication or transmission issue 3
Device operates differently than expected 3
Computer software issue 3
Device displays error message 3
Incorrect display 2
Failure to transmit record 2
Incorrect interpretation of rhythm 1
Failure to read input signal 1
Device inoperable 1
Use of Device Issue 1
No display or display failure 1
Device sensing issue 1
Programming issue 1
Total Device Problems 128

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

Recalls
Manufacturer Recall Class Date Posted
1 Del Mar Reynolds Medical, Ltd. II Jan-13-2012
2 Edan Instruments, Inc. II Oct-12-2011
3 GE Medical Systems, LLC II Jan-21-2010
4 Medtronic Inc. Cardiac Rhythm Managment III Nov-06-2007
5 Mortara Instrument, Inc II Jun-12-2015
6 Philips Healthcare Inc. II Jun-17-2011
7 Philips Medical Systems II Jan-30-2008

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