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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description Carbon dioxide gas analyzer.
Product CodeCCK
Regulation Number 868.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
  1.  K021576  MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MO ...
  2.  K031411  MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
  3.  K031814  STATCO2METER, MODEL 10-55372
  4.  K083056  NEO-STAT CO2
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 3
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 5
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
ICOR
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 3
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 5
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
  1.  K021576  MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MO ...
  2.  K031411  MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
  3.  K031814  STATCO2METER, MODEL 10-55372
  4.  K083056  NEO-STAT CO2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 11
NONIN
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 5
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 2
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material separation 1
Device Issue 1
Defective item 1
No code available 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 1 0 2 0 1
Class II 0 0 2 3 2 4 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Limited I Sep-08-2009
2 Oridion Medical 1987 Ltd. II Mar-30-2012
3 Oridion Medical 1987 Ltd. II Mar-29-2012
4 Oridion Medical 1987 Ltd. I May-25-2011
5 Oridion Medical 1987 Ltd. II Jul-13-2010
6 Oridion Medical 1987 Ltd. II Sep-21-2009
7 Philips Healthcare Inc. I May-26-2011
8 Philips Healthcare Inc. II Apr-08-2010
9 SALTER LABS II Jun-27-2012
10 SALTER LABS II Jan-11-2012
11 Salter Laboratories, Division of Regulatory Affairs II May-23-2011
12 Salter Laboratories, Division of Regulatory Affairs II May-20-2011
13 Smiths Medical ASD, Inc. I Mar-29-2013
14 Smiths Medical PM, Inc. II Mar-02-2010
15 Smiths Medical PM, Inc. II May-15-2009

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