FDA 510(k) Applications Submitted by DATEX-OHMEDA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K081844 |
06/30/2008 |
GE DATEX-OHMEDA AVANCE |
DATEX-OHMEDA, INC. |
| K081842 |
06/30/2008 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA, INC. |
| K072512 |
09/06/2007 |
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) |
DATEX-OHMEDA, INC. |
| K031124 |
04/08/2003 |
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR |
DATEX-OHMEDA, INC. |
| K031479 |
05/08/2003 |
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 |
DATEX-OHMEDA, INC. |
| K012924 |
08/31/2001 |
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER |
DATEX-OHMEDA, INC. |
| K001688 |
06/02/2000 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
| K993512 |
10/18/1999 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
| K050055 |
01/11/2005 |
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM |
DATEX-OHMEDA, INC. |
| K050597 |
03/09/2005 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
| K050626 |
03/11/2005 |
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM |
DATEX-OHMEDA, INC. |
| K050676 |
03/16/2005 |
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) |
DATEX-OHMEDA, INC. |
| K040743 |
03/23/2004 |
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM |
DATEX-OHMEDA, INC. |
| K060862 |
03/29/2006 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
| K050860 |
04/05/2005 |
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR |
DATEX-OHMEDA, INC. |
| K041524 |
06/08/2004 |
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM |
DATEX-OHMEDA, INC. |
| K061609 |
06/09/2006 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
| K041775 |
07/01/2004 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
| K051895 |
07/13/2005 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
| K062710 |
09/11/2006 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
| K073707 |
12/31/2007 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
| K042154 |
08/10/2004 |
GE DATEX-OHMEDA AISYS CARESTATION |
DATEX-OHMEDA, INC. |
| K990132 |
01/14/1999 |
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC |
DATEX-OHMEDA, INC. |
| K000275 |
01/31/2000 |
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA |
DATEX-OHMEDA, INC. |
| K000706 |
03/02/2000 |
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR |
DATEX-OHMEDA, INC. |
| K002878 |
09/15/2000 |
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER |
DATEX-OHMEDA, INC. |
| K993410 |
10/12/1999 |
DATES-OHMEDA AESTIVA SMARTVENT MRI |
DATEX-OHMEDA, INC. |
| K151570 |
06/10/2015 |
Carestation 620/650/650C |
DATEX-OHMEDA, INC. |
| K132530 |
08/12/2013 |
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) |
DATEX-OHMEDA, INC. |
| K123125 |
10/04/2012 |
GE DATEX-OHMEDA AVANCE CS2 |
DATEX-OHMEDA, INC. |
| K110213 |
01/25/2011 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
| K090233 |
01/30/2009 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
| K112722 |
09/19/2011 |
GE DATEX-OHMEDA AVANCE |
DATEX-OHMEDA, INC. |
| K000647 |
02/28/2000 |
DATEX-OHMEDA NETWORK AND CENTRAL |
DATEX-OHMEDA, INC. |
| K000892 |
03/20/2000 |
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES |
DATEX-OHMEDA, INC. |
| K992181 |
06/28/1999 |
TRIP TONOMETRY CATHETER, 8F |
DATEX-OHMEDA, INC. |
| K002158 |
07/17/2000 |
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE |
DATEX-OHMEDA, INC. |
| K993296 |
10/01/1999 |
TRIP TONOMETRY CATHETER, 14F |
DATEX-OHMEDA, INC. |
| K043120 |
11/12/2004 |
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER |
DATEX-OHMEDA, INC. |
| K010463 |
02/16/2001 |
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES |
DATEX-OHMEDA, INC. |
| K992323 |
07/12/1999 |
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES |
DATEX-OHMEDA, INC. |
| K002478 |
08/11/2000 |
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 |
DATEX-OHMEDA, INC. |
| K993608 |
10/25/1999 |
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) |
DATEX-OHMEDA, INC. |
| K993656 |
10/29/1999 |
DATEX-OHMEDA TONOMETRY MODULE M-TONO |
DATEX-OHMEDA, INC. |
| K213867 |
12/10/2021 |
Carestation 750/750c |
Datex-Ohmeda, Inc. |
| K021955 |
06/14/2002 |
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES |
DATEX-OHMEDA, INC. |
| K023366 |
10/08/2002 |
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS |
DATEX-OHMEDA, INC. |
| K170872 |
03/23/2017 |
Aisys CS2 |
Datex-Ohmeda, Inc. |
| K143530 |
12/12/2014 |
Aespire View |
Datex-Ohmeda, Inc. |
| K040831 |
03/31/2004 |
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 |
DATEX-OHMEDA, INC. |
| K983684 |
10/20/1998 |
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS |
DATEX-OHMEDA, INC. |
| K140575 |
03/06/2014 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA, INC. |
| K142679 |
09/19/2014 |
CARESCAPE R860 |
Datex-Ohmeda, Inc. |
| K210384 |
02/09/2021 |
CARESCAPE R860 |
Datex-Ohmeda, Inc. |
| K172045 |
07/06/2017 |
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 |
Datex-Ohmeda, Inc. |
| K172702 |
09/07/2017 |
Tec 820, Tec 850 |
Datex-Ohmeda, Inc. |
| K031027 |
04/01/2003 |
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) |
DATEX-OHMEDA, INC. |
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