FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K960980 |
AIR-SHIELDS, INC. |
ISOLETTE INFANT INCUBATOR |
07/30/1996 |
K021809 |
ATOM MEDICAL CORP. |
V-2100G ADVANCED INFANT INCUBATOR |
07/18/2002 |
K102226 |
ATOM MEDICAL CORPORATION |
DUAL INCU I |
01/04/2011 |
K102279 |
ATOM MEDICAL CORPORATION |
INCU I |
12/29/2010 |
K102710 |
ATOM MEDICAL CORPORATION |
NEO-SERVO I |
12/22/2010 |
K061856 |
ATOM MEDICAL INC |
V-2200 INFANT INCUBATOR |
09/28/2006 |
K132543 |
BISTOS CO., LTD. |
INFANT INCUBATOR |
07/03/2014 |
K040910 |
CHOONGWAE MEDICAL CORP. |
INFANT INCUBATOR, MODEL CHS-I1000 |
04/21/2004 |
K213553 |
Datex Ohmeda Inc. |
Giraffe Incubator Carestation CS1 |
03/02/2022 |
K072512 |
DATEX-OHMEDA, INC. |
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) |
10/03/2007 |
K053399 |
DRAEGER MEDICAL INFANT CARE, INC. |
VERSALET 7700 CARE CENTER |
08/04/2006 |
K182977 |
Draeger Medical Systems, Inc. |
Isolette 8000 Plus |
11/21/2018 |
K172154 |
Draeger Medical Sytems, Inc. |
Isolette 8000 plus |
04/19/2018 |
K980886 |
DRAEGER MEDICAL, INC. |
BABYTHERM 8000 LDR |
05/29/1998 |
K162821 |
Draegerwerk AG & Co. KGaA |
Babyleo TN500 |
06/23/2017 |
K003067 |
DRAGER MEDIZINTECHNIK GMBH |
CALEO |
12/13/2000 |
K954204 |
DRAGER, INC. |
DRAGER INCUBATOR 8000 IC |
04/25/1997 |
K182859 |
Dragerwerk AG & Co. KGaA |
Babyleo TN500 |
02/22/2019 |
K071175 |
GE HEALTHCARE |
OHMEDA MEDICAL GIRAFFE OMNIBED |
07/17/2007 |
K001242 |
HILL-ROM AIR-SHIELDS |
ISOLETTE INFANT INCUBATOR, MODEL C2HS |
07/13/2000 |
K993051 |
HILL-ROM AIR-SHIELDS |
VERSALET 7700 CARE CENTER, MODEL # 7700 |
02/03/2000 |
K031387 |
HILL-ROM MANUFACTURING, INC. |
ISOLETTE INFANT INCUBATOR, MODEL C2000E |
08/01/2003 |
K070291 |
MEDIX I.C.S.A. |
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX |
09/21/2007 |
K061280 |
NEOFORCE GROUP, INC. |
V-2200 INFANT INCUBATOR |
06/27/2006 |
K190494 |
Ningbo David Medical Device Co.,Ltd |
Infant Incubator |
11/25/2019 |
K040068 |
OHMEDA MEDICAL |
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM |
04/16/2004 |
K993712 |
OHMEDA MEDICAL |
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM |
11/09/1999 |
K101778 |
OHMEDA MEDICAL |
GIRAFFE INCUBATOR |
07/21/2010 |
K101788 |
OHMEDA MEDICAL |
GIRAFFE OMNIBED |
07/21/2010 |
K010222 |
OHMEDA MEDICAL |
OHMEDA MEDICAL GIRAFFE INCUBATOR |
03/21/2001 |
K020547 |
OHMEDA MEDICAL |
OHMEDA MEDICAL GIRAFFE INCUBATOR |
05/09/2002 |
K020543 |
OHMEDA MEDICAL |
OHMEDA MEDICAL GIRAFFE OMNIBED |
05/09/2002 |
K993407 |
OHMEDA MEDICAL |
OHMEDA MEDICAL OMNIBED |
01/05/2000 |
K962806 |
OHMEDA MEDICAL |
OHMEDA-OHIO CAE PLUS INCUBATOR |
09/20/1996 |
K974349 |
OHMEDA MEDICAL |
OHMEDA-OHIO CARE PLUS INCUBATOR |
02/12/1998 |
K152809 |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. |
Giraffe Incubator Carestation CS1 |
12/31/2015 |
K152814 |
Ohmeda Medical, a Division of Datex-Ohmeda,Inc. A GE Company |
Giraffe OmniBed Carestation CS1 |
03/17/2016 |
K071977 |
TARRY MEDICAL PRODUCTS, INC. |
TARRY MEDICAL TEMPERATURE PROBES |
05/23/2008 |