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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilatory effort recorder
Regulation Description Breathing frequency monitor.
Product CodeMNR
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
COMPUMEDICS
  SUBSTANTIALLY EQUIVALENT 2
DEL MAR.
  SUBSTANTIALLY EQUIVALENT 1
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 2
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burst 1
Improper or incorrect procedure or method 1
Battery issue 1
Temperature issue 1
Total Device Problems 4

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 1 0 0 0 1 2 0 0 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Del Mar Reynolds Medical, Ltd. II Jan-11-2012
2 Embla System Llc II Jun-11-2013
3 Respironics, Inc. II Apr-24-2008
4 SagaTech Electronics, Inc. II Jul-11-2013
5 Ventus Medical, Inc. III Sep-19-2010

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