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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, breathing frequency
Regulation Description Breathing frequency monitor.
Product CodeBZQ
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  3
  SUBSTANTIALLY EQUIVALENT 4
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
NEUROVISION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 3
NON-INVASIVE MONITORING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  1
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1

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 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Salter Laboratories, Division of Regulatory Affairs II Feb-03-2011

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