• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 8
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 3
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 10
GESELLSCHAFT
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 11
LARSEN & TOUBRO LIMITED
  SUBSTANTIALLY EQUIVALENT 15
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
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 11
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN CREATIVE INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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 12
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 4
ZOE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect display 4
Incorrect measurement 3
Image reversal 2
Fire 1
Failure to run on AC/DC 1
Device alarm system issue 1
Not audible alarm 1
Decoupling 1
Overheating of device or device component 1
Failure to power-up 1
Failure to calibrate 1
Arcing 1
Device displays error message 1
Calibration issue 1
Connection issue 1
Device operates differently than expected 1
Therapeutic or diagnostic output failure 1
Total Device Problems 23

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 1 0 2 1 4 3 4 10 4 0
Class III 0 0 0 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 INNOKAS MEDICAL OY II Jan-28-2015
4 Innokas Medical Oy II Nov-11-2015
5 Invivo Corporation II Jan-13-2015
6 Invivo Corporation II Oct-15-2014
7 Invivo Corporation II Oct-01-2014
8 Invivo Corporation II Aug-19-2014
9 Invivo Corporation II Feb-26-2014
10 Invivo Corporation II Feb-14-2014
11 Invivo Corporation II Dec-04-2012
12 Invivo Corporation II Oct-27-2011
13 Invivo Corporation II Oct-25-2011
14 Invivo Corporation II Feb-06-2009
15 Mckesson Information Solutions LLC II Oct-20-2014
16 Mckesson Information Solutions LLC II Oct-08-2014
17 Medrad Inc II Jun-25-2013
18 Medrad Mr Inc II Jan-23-2014
19 Mindray DS USA, Inc. d.b.a. Mindray North America II Jan-27-2013
20 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Aug-14-2014
21 Philips Electronics North America Corporation II Jul-27-2015
22 Philips Healthcare Inc. II Apr-08-2010
23 Remote Diagnostic Technologies Ltd. II May-11-2011
24 Smiths Medical PM, Inc. II Jul-23-2007
25 Sotera Wireless, Inc. II Jul-29-2013
26 Viterion TeleHealthcare Llc II Feb-14-2013
27 Viterion TeleHealthcare Llc II Feb-15-2012
28 Welch Allyn Protocol, Inc II Jan-07-2014
29 Welch Allyn Protocol, Inc II Jul-30-2009

-
-