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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, apnea, facility use
Regulation Description Apnea monitor.
Product CodeFLS
Regulation Number 868.2377
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSEP CORP.
  1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device alarm system issue 5
Defective Alarm 3
Not audible alarm 1
No Known Device Problem 1
Total Device Problems 10

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 0 1 0 0 0 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, Inc. I May-19-2009
2 Respironics, Inc. II Apr-24-2008

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