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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spirometer, monitoring (w/wo alarm)
Regulation Description Monitoring spirometer.
Product CodeBZK
Regulation Number 868.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
NEWPORT
  SUBSTANTIALLY EQUIVALENT 1
NON-INVASIVE MONITORING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
RESPIRONICS, INC.
  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 Respironics Novametrix, LLC. II Sep-30-2011

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