• 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 7
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
Device operates differently than expected 17
Incorrect or inadequate result 15
Temperature issue 13
Device inoperable 9
Device alarm system issue 7
Overheating of device or device component 6
Smoking 5
Device displays error message 5
Device Issue 3
Device handling issue 3
Device sensing issue 3
Loss of power 3
Monitor failure 2
Unable to obtain readings 2
Not audible alarm 2
Self-activation or keying 2
Communication or transmission issue 2
Radiofrequency interference (RFI) 2
Device damaged prior to use 2
Output issue 2
Invalid sensing 1
Use of Device Issue 1
Battery issue 1
Connection issue 1
No Known Device Problem 1
Operating system becomes non-functional 1
Sensor problems 1
Failure to read input signal 1
Failure to select signal 1
Alarm system, failure of message-leads off 1
Incorrect interpretation of rhythm 1
Burn of device or device component 1
Component(s), broken 1
Component falling 1
Failure to discharge 1
No display or display failure 1
Premature elective replacement indicator 1
Total Device Problems 122

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 0 0 1 0 1 0 0
Class III 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

-
-