FDA 510(k) Applications Submitted by JOEL KENT

FDA 510(k) Number Submission Date Device Name Applicant
K190008 01/02/2019 Carescape One GE Healthcare
K000168 01/20/2000 CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) DATEX-OHMEDA
K150298 02/06/2015 Entropy Module, E-ENTROPY-01 GE HEALTHCARE FILAND OY
K070421 02/13/2007 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 GE HEALTHCARE
K000647 02/28/2000 DATEX-OHMEDA NETWORK AND CENTRAL DATEX-OHMEDA, INC.
K200494 02/28/2020 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES GE Healthcare
K230626 03/07/2023 PortraitÖ Central Viewer Application (Portrait CV A01), Portrait Ö Core Services (Portrait CSS01), PortraitÖ Clinical Alarming Unit (Portrait CAU01); PortraitÖ Mobile Patient Monitor (Portrait HUB01), PortraitÖ Sensor Battery (Portrait SBT01), PortraitÖ B GE Medical Systems Information Technologies, Inc.
K030812 03/14/2003 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE DATEX-OHMEDA
K000882 03/20/2000 DATEX-OHMEDA CS/3 TELEMETRY SYSTEM DATEX-OHMEDA
K000892 03/20/2000 DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES DATEX-OHMEDA, INC.
K030990 03/28/2003 DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR DATEX-OHMEDA
K050837 04/01/2005 REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE GE HEALTHCARE
K071020 04/10/2007 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE GE HEALTHCARE
K211171 04/19/2021 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories GE Healthcare Finland Oy
K061185 04/28/2006 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE GE HEALTHCARE
K131223 04/30/2013 CARESCAPE MONITOR B650 GE HEALTHCARE FINLAND OY
K191149 04/30/2019 CARESCAPE B650 GE Healthcare Finland Oy
K191249 05/09/2019 CARESCAPE B450 GE Healthcare Finland Oy
K051217 05/12/2005 DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) GE HEALTHCARE
K191322 05/15/2019 E-EEGX, N-EEGX GE Healthcare Finland Oy
K191323 05/15/2019 Carescape B850 GE Healthcare Finland OY
K131414 05/16/2013 CARESCAPE MONITOR B850 GE HEALTHCARE FINLAND OY
K031781 06/10/2003 DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES DATEX-OHMEDA
K001814 06/15/2000 DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES DATEX-OHMEDA
K992181 06/28/1999 TRIP TONOMETRY CATHETER, 8F DATEX-OHMEDA, INC.
K962638 07/05/1996 TONOCAP, TC-200 AND ACCESSORY CATHETERS INSTRUMENTARIUM CORP.
K061918 07/06/2006 FOLEY CATHETERS WITH TEMPERATURE PROBE GE HEALTHCARE
K051883 07/12/2005 DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. GE HEALTHCARE
K201941 07/13/2020 Monitor B125, Monitor B105 GE Medical Systems Information Technologies, Inc.
K061994 07/14/2006 WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE GE HEALTHCARE
K002158 07/17/2000 S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE DATEX-OHMEDA, INC.
K022485 07/29/2002 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE DATEX-OHMEDA
K022507 07/30/2002 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 DATEX-OHMEDA
K012531 08/06/2001 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX DATEX-OHMEDA
K052145 08/08/2005 DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE HEALTHCARE
K062324 08/09/2006 MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN GE HEALTHCARE
K132533 08/12/2013 CARESCAPE MONITOR B450 GE HEALTHCARE FINLAND OY
K132528 08/12/2013 E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES GE HEALTHCARE FINLAND OY
K132696 08/29/2013 TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR GE HEALTHCARE FINLAND OY
K062580 08/31/2006 GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) GE HEALTHCARE
K062576 08/31/2006 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES GE HEALTHCARE
K052582 09/20/2005 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES GE HEALTHCARE
K983366 09/24/1998 TRIP TONOMETRY CATHETER, 16F DATEX-ENGSTROM, INC.
K013246 09/28/2001 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 DATEX-OHMEDA
K033078 09/29/2003 DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE DATEX-OHMEDA
K213181 09/29/2021 CARESCAPE B650, E-musb GE Healthcare Finland Oy
K052756 09/30/2005 DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM GE HEALTHCARE
K052755 09/30/2005 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT GE HEALTHCARE
K213234 09/30/2021 CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 GE Medical Systems Information Technologies, Inc.
K993296 10/01/1999 TRIP TONOMETRY CATHETER, 14F DATEX-OHMEDA, INC.
K042771 10/05/2004 GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 DATEX-OHMEDA
K213336 10/06/2021 Carescape B850, E-musb GE Healthcare Finland OY
K013387 10/12/2001 DATEX-OHMEDA S/5 WEB VIEWER DATEX-OHMEDA
K013389 10/12/2001 DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES DATEX-OHMEDA
K213363 10/12/2021 CARESCAPE B450, E-musb GE Healthcare Finland Oy
K033281 10/14/2003 DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE DATEX-OHMEDA
K023459 10/15/2002 DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES DATEX-OHMEDA
K973985 10/20/1997 AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) DATEX-ENGSTROM, INC.
K103129 10/22/2010 ENTROPY EASYFIT SENSOR GE HEALTHCARE
K052976 10/24/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES GE HEALTHCARE
K052977 10/24/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES GE HEALTHCARE
K052975 10/24/2005 DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE GE HEALTHCARE
K052972 10/24/2005 DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE HEALTHCARE
K974101 10/30/1997 DATEX-ENGSTROM NETWORK DATEX-ENGSTROM, INC.
K213490 11/01/2021 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P GE Medical Systems Information Technologies, Inc.
K955026 11/02/1995 AS/3 NMT MODULE DATEX MEDICAL INSTRUMENTATION, INC.
K053121 11/07/2005 TRAM MODULE GE HEALTHCARE
K043120 11/12/2004 MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER DATEX-OHMEDA, INC.
K223531 11/23/2022 CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) GE Healthcare Finland Oy
K043276 11/26/2004 DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE DATEX-OHMEDA
K183394 12/07/2018 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO GE Healthcare Finland Oy
K073462 12/10/2007 MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K974747 12/19/1997 CS/3 ARRHYTHMIA WORKSTATION DATEX-ENGSTROM, INC.
K974792 12/22/1997 CS/3(TM) MONITORS* DATEX-ENGSTROM, INC.
K043551 12/23/2004 DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES DATEX-OHMEDA
K143676 12/24/2014 B40i Patient Monitor GE HEALTHCARE FINLAND OY
K980362 01/29/1998 MRI COMPATIBLE MONITOR AND ACCESSORIES DATEX-ENGSTROM, INC.
K980384 02/02/1998 TRIP TONOMETRY CATHETER, 18F DATEX-ENGSTROM, INC.
K020479 02/13/2002 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES DATEX-OHMEDA
K010463 02/16/2001 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES DATEX-OHMEDA, INC.
K000815 03/13/2000 AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) DATEX-OHMEDA
K050835 04/01/2005 DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE
K961441 04/15/1996 TONOMETERED SLAINE BLOOD GAS CONTROL INSTRUMENTARIUM CORP.
K981378 04/16/1998 DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 DATEX-ENGSTROM, INC.
K021279 04/22/2002 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE DATEX-OHMEDA
K021265 04/22/2002 DATEX-OHMEDA HMEF 500 DATEX-OHMEDA
K051092 04/28/2005 DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC GE HEALTHCARE
K021376 05/01/2002 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE DATEX-OHMEDA
K031653 05/28/2003 DATEX-OHMEDA HMEF 750 DATEX-OHMEDA
K011670 05/30/2001 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE DATEX-OHMEDA
K051400 05/31/2005 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS GE HEALTHCARE
K982091 06/15/1998 CS/3 COMPACT AIRWAY MODULE, M-COVX DATEX-ENGSTROM, INC.
K051634 06/20/2005 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION GE HEALTHCARE
K051635 06/20/2005 DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES GE HEALTHCARE
K041772 07/01/2004 DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES DATEX-OHMEDA
K041790 07/02/2004 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE DATEX-OHMEDA
K061907 07/05/2006 MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE
K092027 07/06/2009 CARESCAPE MONITOR B850 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K071889 07/09/2007 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE GE HEALTHCARE
K061942 07/10/2006 TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 GE HEALTHCARE
K051873 07/11/2005 DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES GE HEALTHCARE
K992323 07/12/1999 DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES DATEX-OHMEDA, INC.
K052167 08/09/2005 DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES GE HEALTHCARE
K002478 08/11/2000 S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 DATEX-OHMEDA, INC.
K022740 08/19/2002 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE DATEX-OHMEDA
K012837 08/23/2001 MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES DATEX-OHMEDA
K082540 09/02/2008 GE ENTROPY SENSOR GE HEALTHCARE
K052880 10/12/2005 DATEX-OHMEDA S/5 INTERFACE MODULE E-INT GE HEALTHCARE
K023454 10/15/2002 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES DATEX-OHMEDA
K023497 10/18/2002 DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE DATEX-OHMEDA
K042891 10/19/2004 DATEX-OHMEDA OXY-AFR SENSOR DATEX-OHMEDA
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.
K023641 10/30/2002 DATEX-OHMEDA HMEF MINI DATEX-OHMEDA
K043572 12/27/2004 COMPATIBILITY ECG TRUNK CABLES DATEX-OHMEDA


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact