FDA 510(k) Applications for Medical Device Product Code "FMZ"
(Incubator, Neonatal)

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


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