Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | 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(with arrhythmia detection or alarms)
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeMHX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 5
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 15
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 18
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 43
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
HIDALGO LIMITED
  SUBSTANTIALLY EQUIVALENT 2
INVIVO
  SUBSTANTIALLY EQUIVALENT 3
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LARSEN & TOUBRO LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 13
OBS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 55
SABRATEK
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS
  SUBSTANTIALLY EQUIVALENT 14
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 9
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device alarm system issue 13
Not audible alarm 5
Component falling 4
No Known Device Problem 2
Delayed alarm 2
Loss of power 1
Incorrect interpretation of rhythm 1
Crack 1
Naturally worn 1
Low audible alarm 1
Computer software issue 1
Malfunction 1
Defective Alarm 1
Detachment of device component 1
Device maintenance issue 1
Device stops intermittently 1
Battery issue 1
Total Device Problems 38

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 1 0 0
Class II 2 4 5 7 15 13 4
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CAS Medical Systems, Inc. II Sep-16-2008
2 Datascope Corporation II Jan-17-2008
3 Draeger Medical Systems, Inc. II Aug-22-2011
4 Draeger Medical Systems, Inc. II Aug-26-2010
5 Draeger Medical, Inc. II Mar-11-2013
6 Draeger Medical, Inc. II Nov-23-2011
7 Draeger Medical, Inc. I Nov-22-2011
8 Draeger Medical, Inc. II Dec-29-2009
9 GE Healthcare II Jun-01-2009
10 GE Healthcare, LLC II Feb-14-2013
11 GE Healthcare, LLC II Feb-14-2013
12 GE Healthcare, LLC II Feb-13-2013
13 GE Healthcare, LLC II Dec-16-2012
14 GE Healthcare, LLC II Dec-14-2012
15 GE Healthcare, LLC II Jul-16-2012
16 GE Healthcare, LLC II Aug-25-2011
17 GE Healthcare, LLC II Apr-08-2011
18 GE Healthcare, LLC II Apr-08-2011
19 GE Healthcare, LLC II Mar-03-2011
20 GE Healthcare, LLC II Nov-15-2010
21 GE Healthcare, LLC II Nov-15-2010
22 GE Healthcare, LLC II Aug-25-2010
23 Ge Healthcare, Llc II Jun-11-2010
24 Mindray DS USA, Inc. d.b.a. Mindray North America II Dec-17-2012
25 Mindray DS USA, Inc. d.b.a. Mindray North America II Dec-11-2012
26 Mindray DS USA, Inc. d.b.a. Mindray North America II Aug-28-2012
27 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Jun-10-2010
28 Mindray DS USA, Inc., dba Datascope Patient Monitoring II May-27-2009
29 Mini-Mitter Company, Inc. II Jan-17-2008
30 Philips Healthcare Inc. II Dec-10-2012
31 Philips Healthcare Inc. II Mar-01-2012
32 Philips Healthcare Inc. II Jun-17-2011
33 Philips Healthcare Inc. II May-19-2011
34 Philips Healthcare Inc. II Jan-27-2011
35 Philips Healthcare Inc. II Aug-10-2010
36 Philips Healthcare Inc. II Nov-23-2009
37 Philips Medical Systems II Sep-16-2008
38 Philips Medical Systems II Dec-11-2007
39 Philips Medical Systems II Sep-05-2007
40 Spacelabs Healthcare, Incorporated II Sep-11-2009
41 Spacelabs Healthcare, Llc II Nov-20-2012
42 Spacelabs Healthcare, Llc II Nov-05-2012
43 Spacelabs Healthcare, Llc II Jul-16-2012
44 Spacelabs Healthcare, Llc II Jun-05-2012
45 Spacelabs Healthcare, Llc II Aug-18-2011
46 Spacelabs Healthcare, Llc II Aug-17-2011
47 Spacelabs Healthcare, Llc II Aug-15-2011
48 Spacelabs Healthcare, Llc II Aug-02-2011
49 Spacelabs Healthcare, Llc II Jun-20-2011
50 Spacelabs Healthcare, Llc II May-03-2011
51 Zoe Medical Incorporated II Sep-14-2012

-
-