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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, neonatal phototherapy
Regulation Description Neonatal phototherapy unit.
Product CodeLBI
Regulation Number 880.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMITEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDELA
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIX I.C.S.A.
  SUBSTANTIALLY EQUIVALENT 3
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Component incompatible 1
Component or accessory incompatibility 1
Incompatibility problem 1
No Known Device Problem 1
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. II Jul-06-2012
2 Natus Medical Incorporated II Nov-24-2009

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