• 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, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeDRT
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 7
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLUKE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 4
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 7
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 20
HOANA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 3
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 3
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 10
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 4
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PRESYM, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 8
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
WR MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
ZOE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Temperature issue 42
Unable to obtain readings 29
Device displays error message 25
Device operates differently than expected 24
Overheating of device or device component 19
Incorrect or inadequate result 17
Device inoperable 10
Device alarm system issue 9
Smoking 7
Burn of device or device component 6
Invalid sensing 4
Failure of device to self-test 4
No Known Device Problem 4
Device handling issue 3
Device sensing issue 3
Device Issue 3
Communication or transmission issue 3
Failure to pace or properly pace 3
Loss of power 3
Not audible alarm 3
Failure to analyze rhythm 3
Incorrect interpretation of rhythm 2
Self-activation or keying 2
No display or display failure 2
Incorrect measurement 2
Monitor failure 2
Device damaged prior to use 2
Radiofrequency interference (RFI) 2
Output issue 2
Improper alarm 1
Operating system becomes non-functional 1
Connection issue 1
Battery issue 1
Premature elective replacement indicator 1
Alarm system, failure of message-leads off 1
Use of Device Issue 1
Electro-static discharge 1
Alarm not visible 1
Component(s), broken 1
Component falling 1
Failure to discharge 1
Sensor problems 1
Failure to read input signal 1
Failure to select signal 1
Total Device Problems 255

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ansar Group, Inc. Dba Ansar Medical Technologies, Inc II Aug-19-2014
2 Mindray DS USA, Inc. d.b.a. Mindray North America II Feb-24-2012

-
-