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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, ecg analysis
Product CodeLOS
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GRAHAM-FIELD HEALTH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 7
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 9
MORTARA
  SUBSTANTIALLY EQUIVALENT 6
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QRS
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer software issue 1
Loss of power 1
Incorrect software programming calculations 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Pulse Biomedical Inc II Apr-04-2007
2 Qrs Diagnostic II Mar-23-2012

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