FDA 510(k) Applications for Medical Device Product Code "FMT"
(Warmer, Infant Radiant)

FDA 510(k) Number Applicant Device Name Decision Date
K002355 ATOM MEDICAL CORP. ATOM INFA WARMER V-505 10/10/2000
K102227 ATOM MEDICAL CORPORATION INFA WARMER I 01/21/2011
K120937 ATOM MEDICAL CORPORATION SUNFLOWER WARNER 07/06/2012
K060461 ATOM MEDICAL INC V-505 INFA WARMER 04/28/2006
K952800 CONTOUR MEDICAL TECHNOLOGY, INC. TEMPERATURE PROBE-TP150 04/04/1996
K952801 CONTOUR MEDICAL TECHNOLOGY, INC. TEMPERATURE PROBE-TP250 04/04/1996
K952803 CONTOUR MEDICAL TECHNOLOGY, INC. TEMPERATURE PROBE-TP350 04/04/1996
K952804 CONTOUR MEDICAL TECHNOLOGY, INC. TEMPERATURE PROBE-TP450 04/04/1996
K952805 CONTOUR MEDICAL TECHNOLOGY, INC. TEMPERATURE PROBE-TP550 04/04/1996
K952807 CONTOUR MEDICAL TECHNOLOGY, INC. TEMPERATURE PROBE-TP650 04/04/1996
K213551 Datex Ohmeda Inc. Giraffe Omnibed Carestation CS1 03/02/2022
K200319 DeRoyal Industries, Inc. HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable 04/02/2020
K191425 DeRoyal Industries, Inc. Hydro-Temp Neonatal Skin Temperature Probe Cover 01/21/2020
K230278 Draeger Medical Systems, Inc. Babyroo TN300 05/30/2023
K120642 Draeger Medical Systems, Inc. RESUSCITAIRE WITH AUTOBREATH 11/02/2012
K971198 DRAGER, INC. BABYTHERM 8004 BABYTHERM 8010 10/03/1997
K953489 DRAGER, INC. DRAGER INFANT RADIANT WARMERN RH600 02/09/1996
K950422 FIRST TOUCH DISPOSABLES, INC. FIRST TOUCH DISPOSABLES TEMPERATURE PROBES 01/23/1997
K970432 FISHER & PAYKEL ELECTRONICS LTD. INFANT RADIANT WARMER - MODELS IW910 AND IW920 05/07/1997
K971695 FISHER & PAYKEL ELECTRONICS LTD. SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER 07/28/1997
K972885 FISHER & PAYKEL ELECTRONICS LTD. SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 10/30/1997
K971461 FISHER & PAYKEL ELECTRONICS LTD. SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) 07/16/1997
K201628 GE Healthcare Panda iRes Warmer, Giraffe Warmer 02/12/2021
K003335 HILL-ROM AIR-SHIELDS RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER 11/17/2000
K971366 HILL-ROM, INC. INCUWARMER 01/05/1998
K970074 HILL-ROM, INC. STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) 04/03/1997
K173516 International Biomedical NuBorne Infant Warmer 08/17/2018
K033040 INTERNATIONAL HOSPITAL SUPPLY CO. PHOENIX INFANT RADIANT WARMER, MODEL 100NWS 12/17/2003
K960080 KENTEC MEDICAL, INC. ACCUTEMP PROBE 05/01/1996
K970686 KENTEC MEDICAL, INC. ACCUTEMP-PROBE 08/25/1997
K964401 LUDLOW TECHNICAL PRODUCTS KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) 02/06/1997
K012229 NATIONAL CUSTOM ENT., INC. SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC 09/10/2001
K070377 OHMEDA MEDICAL GIRAFFE AND PANDA WARMER 07/11/2007
K123309 OHMEDA MEDICAL GIRAFFE AND PANDA WARMERS 02/05/2013
K963058 OHMEDA MEDICAL INFANT WARMER SYSTEM 10/01/1996
K072157 OHMEDA MEDICAL MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) 08/27/2007
K090697 OHMEDA MEDICAL MODIFICATION TO: GIRAFFE AND PANDA WARMER 04/16/2009
K101804 OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., GIRAFFE AND PANDA WARMERS 07/21/2010
K122267 OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., GIRAFFE AND PANDA WARMERS 10/02/2012
K020966 REPLACEMENT PARTS INDUSTRIES, INC. RPI REPLACEMENT HEATING ELEMENTS 06/13/2002
K020219 REPLACEMENT PARTS INDUSTRIES, INC. RPI SKIN OR AIR TEMPERATURE PROBE 04/12/2002
K121625 WIPRO GE HEALTHCARE PRIVATE, LTD. LULLABY TM WARMER 09/14/2012


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