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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter
Regulation Description Oximeter.
Product CodeDQA
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 7
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 14
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
CONMED
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 7
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 8
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTH HERO NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 7
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 2
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 4
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 65
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 21
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 6
NONIN
  SUBSTANTIALLY EQUIVALENT 34
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 8
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
PALCO LABS, INC
  SUBSTANTIALLY EQUIVALENT 4
PHD MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 15
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QRS
  SUBSTANTIALLY EQUIVALENT 1
QUANTA COMPUTER INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 6
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 3
Sharp Corporation
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 6
SMITHS
  SUBSTANTIALLY EQUIVALENT 5
SOMANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
UNIMED
  SUBSTANTIALLY EQUIVALENT 1
VENTREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Incorrect or inadequate result 24
Device alarm system issue 7
Defective Alarm 5
Drift 5
Not audible alarm 4
Malfunction 3
Burn of device or device component 2
Component(s), broken 2
Melted 2
Overheating of device or device component 2
Incorrect display 1
Incorrect measurement 1
Stretched 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Component(s), overheating of 1
Contamination during use 1
Misconnection 1
Device stops intermittently 1
Device inoperable 1
Fitting problem 1
Reset issue 1
Measurements, inaccurate 1
False reading from device non-compliance 1
Loss of power 1
Failure to power-up 1
Out-of-box failure 1
Total Device Problems 73

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

Recalls
Manufacturer Recall Class Date Posted
1 Dixtal Medical, Inc. II Dec-09-2010
2 Dixtal Medical, Inc. II Jun-28-2009
3 General Electric Medical Systems Information Technology II Jan-13-2010
4 International Technidyne Corp. II May-19-2011
5 International Technidyne Corp. II Aug-06-2008
6 Kentec Medical Inc II Jun-26-2008
7 Masimo Corporation II Apr-29-2013
8 Masimo Corporation II Feb-22-2011
9 Medtronic, Inc. II Oct-31-2007
10 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-15-2010
11 Nonin Medical, Inc II Apr-11-2008
12 Oridion Capnography Inc II Nov-28-2007
13 Philips Healthcare Inc. II Apr-08-2010
14 Philips Medical Systems II Oct-10-2008
15 Philips Medical Systems III Sep-18-2008
16 Smiths Medical PM, Inc. II Mar-02-2010
17 Smiths Medical PM, Inc. II Aug-15-2008
18 Smiths Medical PM, Inc. III Sep-21-2007

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