FDA 510(k) Applications for Medical Device Product Code "BSZ"
(Gas-Machine, Anesthesia)
| 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 |
| K251352 | Codonics.Incorporated | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | 07/11/2025 |
| 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 |
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