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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor,physiological,patient(without arrhythmia detection or alarms)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeMWI
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 11
AIRSTRIP TECHNOLOGIES, LP
  SUBSTANTIALLY EQUIVALENT 5
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 3
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 9
GESELLSCHAFT
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 8
LARSEN & TOUBRO LIMITED
  SUBSTANTIALLY EQUIVALENT 15
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORAV MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
OBS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
OXFORD BIOSIGNALS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SOMANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TELEMEDIC SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 1
VISUAL TELECOMMUNICATIONS NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 9
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Not audible alarm 1
Fire 1
Failure to power-up 1
Device displays error message 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 2 1 4 3 2
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Capsule Tech Inc. II Sep-13-2012
2 Capsule Tech Inc. II Jun-01-2011
3 Invivo Corporation II Dec-04-2012
4 Invivo Corporation II Oct-27-2011
5 Invivo Corporation II Oct-25-2011
6 Invivo Corporation II Feb-06-2009
7 Mindray DS USA, Inc. d.b.a. Mindray North America II Jan-27-2013
8 Philips Healthcare Inc. II Apr-08-2010
9 Remote Diagnostic Technologies Ltd. II May-11-2011
10 Smiths Medical PM, Inc. II Jul-23-2007
11 Viterion TeleHealthcare Llc II Feb-14-2013
12 Viterion TeleHealthcare Llc II Feb-15-2012
13 Welch Allyn Protocol, Inc II Jul-30-2009

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