FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K052335 |
ACCUTRON, INC. |
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA |
11/23/2005 |
K992421 |
ACCUTRON, INC. |
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 |
10/27/1999 |
K120075 |
ADVANCED INSTRUMENTATIONS, INC. |
AM-6000 ANESTHESIA MACHINE |
01/26/2012 |
K982137 |
BLEASE MEDICAL EQUIPMENT LTD. |
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE |
04/09/1999 |
K003251 |
BLEASE MEDICAL EQUIPMENT LTD. |
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 |
05/23/2001 |
K041430 |
BLEASE MEDICAL EQUIPMENT LTD. |
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 |
10/07/2004 |
K001727 |
BLEASE MEDICAL EQUIPMENT LTD. |
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES |
08/09/2000 |
K051629 |
BLEASE USA, INC. |
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 |
09/23/2005 |
K012446 |
CHARLES A. SMITH |
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI |
10/03/2001 |
K000859 |
CHARLES A. SMITH |
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 |
08/23/2000 |
K101439 |
CODONICS, INC. |
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P |
02/07/2011 |
K123211 |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
A5 ANESTHESIA DELIVERY SYSTEM |
02/14/2013 |
K080175 |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 |
06/09/2008 |
K973985 |
DATEX-ENGSTROM, INC. |
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) |
10/30/1998 |
K122445 |
DATEX-OHMEDA |
AESPIRE 7900, AESPIRE VIEW |
10/12/2012 |
K032803 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM |
03/10/2004 |
K071142 |
DATEX-OHMEDA |
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM |
06/06/2007 |
K131945 |
DATEX-OHMEDA |
GE DATEX-OHMEDA AVANCE CS2 |
08/08/2013 |
K092864 |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
AESPIRE 7900, AESPIRE VIEW |
01/12/2010 |
K143530 |
Datex-Ohmeda, Inc. |
Aespire View |
04/24/2015 |
K172045 |
Datex-Ohmeda, Inc. |
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 |
11/03/2017 |
K170872 |
Datex-Ohmeda, Inc. |
Aisys CS2 |
08/15/2017 |
K151570 |
DATEX-OHMEDA, INC. |
Carestation 620/650/650C |
01/21/2016 |
K213867 |
Datex-Ohmeda, Inc. |
Carestation 750/750c |
03/28/2023 |
K993410 |
DATEX-OHMEDA, INC. |
DATES-OHMEDA AESTIVA SMARTVENT MRI |
04/25/2000 |
K000706 |
DATEX-OHMEDA, INC. |
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR |
05/11/2000 |
K050626 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM |
03/25/2005 |
K050055 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM |
02/04/2005 |
K061609 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AISYS |
06/27/2006 |
K073707 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AISYS |
01/30/2008 |
K090233 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AISYS |
03/05/2009 |
K110213 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AISYS |
07/20/2011 |
K042154 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AISYS CARESTATION |
08/31/2004 |
K132530 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) |
12/20/2013 |
K081844 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AVANCE |
08/29/2008 |
K112722 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AVANCE |
12/16/2011 |
K123125 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA AVANCE CS2 |
02/06/2013 |
K050676 |
DATEX-OHMEDA, INC. |
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) |
04/12/2005 |
K040743 |
DATEX-OHMEDA, INC. |
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM |
04/22/2004 |
K062388 |
DOCUSYS |
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM |
02/22/2007 |
K072884 |
DRAEGER MEDICAL AG & CO. KG |
FABIUS MRI |
07/30/2008 |
K081447 |
DRAEGER MEDICAL AG & CO. KG |
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO |
10/08/2008 |
K133886 |
DRAEGER MEDICAL GMBH |
PERSEUS A500 |
06/20/2014 |
K103035 |
DRAEGER MEDICAL GMBH |
SMARTPILOT VIEW MODEL MK04500 |
03/28/2012 |
K011404 |
DRAEGER MEDICAL, INC. |
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS |
02/22/2002 |
K042086 |
DRAEGER MEDICAL, INC. |
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM |
08/31/2004 |
K042419 |
DRAEGER MEDICAL, INC. |
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM |
10/08/2004 |
K031400 |
DRAEGER MEDICAL, INC. |
FABIUS TIRO ANESTHESIA SYSTEM |
07/15/2003 |
K983635 |
DRAEGER MEDICAL, INC. |
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN |
01/11/1999 |
K030624 |
DRAEGER MEDICAL, INC. |
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM |
03/17/2004 |
K041622 |
DRAEGER MEDICAL, INC. |
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM |
07/08/2004 |
K980553 |
DRAEGER MEDICAL, INC. |
NARKOMED 6000 MODEL NUMBER NM6000 |
08/04/1998 |
K033498 |
DRAEGER MEDICAL, INC. |
NARKOMED 6400, MODEL NM6400 |
04/26/2004 |
K963994 |
DRAEGER MEDICAL, INC. |
NARKOMED GS ANESTHESIA SYSTEM |
03/19/1997 |
K971425 |
DRAEGER MEDICAL, INC. |
NARKOMED M ANESTHESIA SYSTEM (M) |
09/10/1997 |
K001488 |
DRAEGER MEDICAL, INC. |
NARKOMED MRI , NM-MRI |
06/09/2000 |
K972848 |
DRAEGER MEDICAL, INC. |
NARKOMED MRI ANESTHESIA SYSTEM |
10/30/1997 |
K022031 |
DRAEGER MEDICAL, INC. |
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 |
08/29/2002 |
K003579 |
DRAEGER MEDICAL, INC. |
NARKOMED MRI-2, MODEL NM-MRI-2 |
01/22/2001 |
K974193 |
DRAEGER MEDICAL, INC. |
NARKOMED ULTRASONIC FLOW SENSOR |
01/28/1998 |
K973949 |
DRAEGER MEDICAL, INC. |
PERIOPERATIVE DATA MANAGEMENT SYSTEM |
02/06/1998 |
K042607 |
DRAEGER MEDICAL, INC. |
PRIMUS US |
11/26/2004 |
K132903 |
DRE MEDICAL, INC. |
DRE VENTURA |
07/01/2014 |
K230931 |
DrΣgerwerk AG Co. KGaA |
Atlan |
07/23/2023 |
K090892 |
GE HEALTHCARE FINLAND OY |
GE DATEX-OHMEDA S/5 ADU CARESTATION |
04/30/2009 |
K071097 |
GE HEALTHCARE FINLAND OY |
NAVIGATOR APPLICATIONS SUITE |
10/10/2007 |
K081941 |
GE HEALTHCARE FINLAND OY |
NAVIGATOR APPLICATIONS SUITE |
08/07/2008 |
K083098 |
GE HEALTHCARE FINLAND OY |
NAVIGATOR APPLICATIONS SUITE |
04/01/2009 |
K102389 |
GE HEALTHCARE FINLAND OY |
NAVIGATOR APPLICATIONS SUITE |
06/10/2011 |
K965160 |
HEWLETT-PACKARD GMBH |
HP ORVUE INTRA-OP (M2510A) |
09/11/1997 |
K963481 |
HEYER AMERICA, INC. |
ANODYNE CC |
08/11/1997 |
K001988 |
HEYER AMERICA, INC. |
MODULAR |
02/05/2001 |
K000995 |
HEYER AMERICA, INC. |
NARKOMAT, MODEL 2000 |
10/11/2000 |
K033026 |
MALLARD MEDICAL, INC. |
MALLARD MODEL 3000 ANESTHESIA MACHINE |
09/03/2004 |
K133958 |
MAQUET CRITICAL CARE AB |
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 |
03/20/2014 |
K160665 |
MAQUET CRITICAL CARE AB |
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 |
03/29/2017 |
K191027 |
Maquet Critical Care AB |
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System |
03/18/2020 |
K112114 |
MAQUET CRITICAL CARE AB |
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 |
01/13/2012 |
K102182 |
MAQUET CRITICAL CARE AB |
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 |
05/09/2011 |
K113633 |
MCKESSON TECHNOLOGIES INC. |
MCKESSON ANESTHESIA CARE |
04/20/2012 |
K971030 |
MEDICAL AND INDUSTRIAL EQUIPMENT |
MIE FALCON, DATEX ENGSTROM FLEXIMA II |
11/12/1997 |
K981845 |
MEDICAL INDUSTRIAL EQUIPMENT |
HAWK ANAESTHESIA INDUCTION UNIT |
11/03/1998 |
K102471 |
MINDRAY DS USA, INC. |
AS3700 ANESTHSIA DELIVERY SYSTEM |
02/11/2011 |
K060193 |
OCEANIC MEDICAL PRODUCTS, INC. |
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 |
04/10/2006 |
K010613 |
OCEANIC MEDICAL PRODUCTS, INC. |
MAGELLAN-2200, MODEL 1 |
10/12/2001 |
K072420 |
OCEANIC MEDICAL PRODUCTS, INC. |
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE |
01/22/2008 |
K965041 |
OHMEDA MEDICAL |
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM |
06/17/1997 |
K973896 |
OHMEDA MEDICAL |
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM |
04/21/1998 |
K946127 |
OHMEDA MEDICAL |
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM |
10/08/1996 |
K131790 |
ORICARE, INC. |
A9800 ANESTHESIA WORKSTATION |
05/09/2014 |
K061102 |
PENLON LTD. |
PRIMA ANAESTHESIA MACHINE |
07/28/2006 |
K122063 |
PHILIPS ANESTHESIA CARE |
INTELLISAVE AX700 ANESTHESIA SYSTEM |
08/02/2013 |
K083413 |
PHILIPS MEDICAL SYSTEMS |
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM |
12/18/2008 |
K030939 |
PHILIPS MEDICAL SYSTEMS |
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE |
07/15/2003 |
K062155 |
PORTER INSTRUMENT CO., INC. |
DIGITAL MXR-D FLOWMETER |
11/09/2006 |
K050883 |
SAFER SLEEP LLC |
SAFERSLEEP SYSTEM |
11/04/2005 |
K142552 |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
A7 Anesthesia System |
01/23/2015 |
K171311 |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
A5 Anesthesia System |
01/12/2018 |
K171292 |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
A7 Anesthesia System |
01/12/2018 |
K151954 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
A7 Anesthesia System |
10/27/2015 |
K201957 |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
A8, A9 Anesthesia System |
03/26/2021 |
K001315 |
SIEMENS ELEMA AB |
MODIFICATION TO KION ANESTHESIA SYSTEM |
05/26/2000 |
K973971 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KION ANESTHESIA SYSTEM |
09/13/1999 |
K981530 |
SPACELABS MEDICAL, INC. |
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM |
11/20/1998 |
K003663 |
SPACELABS MEDICAL, INC. |
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE |
06/28/2001 |
K970163 |
TECHNICAL MEDICAL PRODUCTS, INC. |
ALPHA MX (20)/ULTRA PC (30) |
12/10/1997 |
K140264 |
THORNHILL RESEARCH INC. |
MADM |
01/05/2015 |