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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device incubator, neonatal
Regulation Description Neonatal incubator.
Product CodeFMZ
Regulation Number 880.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 4
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 3
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIX I.C.S.A.
  SUBSTANTIALLY EQUIVALENT 2
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 15
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K801461  THERMA-SHIELD
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
TARRY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unstable 2
Inadequate instructions for non-healthcare professional 1
Moisture or humidity problem 1
No Known Device Problem 1
Device alarm system issue 1
Mechanical issue 1
Probe failure 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 1 0 0 0
Class II 0 2 0 0 1 1 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atom Medical Corporation II Jul-06-2012
2 Atom Medical Corporation II Dec-01-2011
3 Datex Ohmeda, Inc. dba GE Healthcare II Nov-21-2008
4 Draeger Medical, Inc. II Mar-18-2008
5 GE Healthcare, LLC I Apr-05-2013
6 Maquet Datascope Corp - Cardiac Assist Division I Jun-13-2011
7 Natus Medical Incorporated II Apr-11-2016

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