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 |