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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
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 2

Device Problems
Failure to power-up 2
Shock, electrical 1
Leak 1
No Information 1
Component(s), overheating of 1
Total Device Problems 6

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 0 0 1 1 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Alivecor SFO III Feb-18-2015
2 Cybernet Systems Corp. II Feb-25-2010
3 Lifewatch Services Inc II Nov-17-2011
4 Spacelabs Healthcare Inc II Oct-30-2015

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