• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
  1.  K010222  OHMEDA MEDICAL GIRAFFE INCUBATOR
  2.  K020543  OHMEDA MEDICAL GIRAFFE OMNIBED
  3.  K020547  OHMEDA MEDICAL GIRAFFE INCUBATOR
  4.  K040068  BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
  5.  K101778  GIRAFFE INCUBATOR
  6.  K101788  GIRAFFE OMNIBED
  7.  K871399  OHIO(R) CARE PLUS INCUBATOR
  8.  K901585  OHMEDA - OHIO(R) CARE PLUS INCUBATOR
  9.  K913154  OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
  10.  K914487  OHIO CARE PLUS INCUBATOR
  11.  K943360  OHIO CARE PLUS INCUBATOR
  12.  K962806  OHMEDA-OHIO CAE PLUS INCUBATOR
  13.  K974349  OHMEDA-OHIO CARE PLUS INCUBATOR
  14.  K993407  OHMEDA MEDICAL OMNIBED
  15.  K993712  BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
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
Device alarm system issue 1
Mechanical issue 1
Probe failure 1
Total Device Problems 7

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

-
-