Product Code: BSZ FDA class 2 21 CFR 868.5160

Gas-Machine, Anesthesia

Anesthesiology

The Gas-Machine, Anesthesia is a complex medical device that delivers precise and controlled mixtures of anesthetic gases and oxygen to a patient during surgical procedures, typically integrated with a ventilator and monitoring components. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BSZ, regulated under 21 CFR 868.5160 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

188

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: BSZ
Device Class: FDA class 2
Regulation Number: 868.5160
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 188 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252746	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	May 21, 2026	Substantially Equivalent	Drägerwerk AG Co. Kgaa
K251352	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)	Jul 11, 2025	Substantially Equivalent	Codonics.Incorporated
K230931	Atlan	Jul 23, 2023	Substantially Equivalent	Drägerwerk AG Co. Kgaa
K213867	Carestation 750/750c	Mar 28, 2023	Substantially Equivalent	Datex-Ohmeda, Inc.
K201957	A8, A9 Anesthesia System	Mar 26, 2021	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K191027	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System	Mar 18, 2020	Substantially Equivalent	Maquet Critical Care AB
K171311	A5 Anesthesia System	Jan 12, 2018	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K171292	A7 Anesthesia System	Jan 12, 2018	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K172045	Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2	Nov 03, 2017	Substantially Equivalent	Datex-Ohmeda, Inc.
K170872	Aisys CS2	Aug 15, 2017	Substantially Equivalent	Datex-Ohmeda, Inc.
K160665	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40	Mar 29, 2017	Substantially Equivalent	Maquet Critical Care AB
K151570	Carestation 620/650/650C	Jan 21, 2016	Substantially Equivalent	Datex-Ohmeda, Inc.
K151954	A7 Anesthesia System	Oct 27, 2015	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K143530	Aespire View	Apr 24, 2015	Substantially Equivalent	Datex-Ohmeda, Inc.
K142552	A7 Anesthesia System	Jan 23, 2015	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K140264	MADM	Jan 05, 2015	Substantially Equivalent	Thornhill Research, Inc.
K132903	DRE VENTURA	Jul 01, 2014	Substantially Equivalent	Dre Medical, Inc.
K133886	PERSEUS A500	Jun 20, 2014	Substantially Equivalent	Draeger Medical GmbH
K131790	A9800 ANESTHESIA WORKSTATION	May 09, 2014	Substantially Equivalent	Oricare, Inc.
K133958	FLOW-I ANESTHESIA SYSTEM C20, C30 & C40	Mar 20, 2014	Substantially Equivalent	Maquet Critical Care AB
K132530	GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)	Dec 20, 2013	Substantially Equivalent	Datex-Ohmeda, Inc.
K131945	GE DATEX-OHMEDA AVANCE CS2	Aug 08, 2013	Substantially Equivalent	Datex-Ohmeda
K122063	INTELLISAVE AX700 ANESTHESIA SYSTEM	Aug 02, 2013	Substantially Equivalent	Philips Anesthesia Care
K123211	A5 ANESTHESIA DELIVERY SYSTEM	Feb 14, 2013	Substantially Equivalent	Datascope Corp., Patient Monitoring Division
K123125	GE DATEX-OHMEDA AVANCE CS2	Feb 06, 2013	Substantially Equivalent	Datex-Ohmeda, Inc.
K122445	AESPIRE 7900, AESPIRE VIEW	Oct 12, 2012	Substantially Equivalent	Datex-Ohmeda
K113633	MCKESSON ANESTHESIA CARE	Apr 20, 2012	Substantially Equivalent	Mckesson Technologies, Inc.
K103035	SMARTPILOT VIEW MODEL MK04500	Mar 28, 2012	Substantially Equivalent	Draeger Medical GmbH
K120075	AM-6000 ANESTHESIA MACHINE	Jan 26, 2012	Substantially Equivalent	Advanced Instrumentations, Inc.
K112114	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40	Jan 13, 2012	Substantially Equivalent	Maquet Critical Care AB
K112722	GE DATEX-OHMEDA AVANCE	Dec 16, 2011	Substantially Equivalent	Datex-Ohmeda, Inc.
K110213	GE DATEX-OHMEDA AISYS	Jul 20, 2011	Substantially Equivalent	Datex-Ohmeda, Inc.
K102389	NAVIGATOR APPLICATIONS SUITE	Jun 10, 2011	Substantially Equivalent	GE Healthcare Finland Oy
K102182	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30	May 09, 2011	Substantially Equivalent	Maquet Critical Care AB
K102471	AS3700 ANESTHSIA DELIVERY SYSTEM	Feb 11, 2011	Substantially Equivalent	Mindray DS USA, Inc.
K101439	CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P	Feb 07, 2011	Substantially Equivalent	Codonics, Inc.
K092864	AESPIRE 7900, AESPIRE VIEW	Jan 12, 2010	Substantially Equivalent	Datex-Ohmeda Inc., A Division of Instrumentarium C
K090892	GE DATEX-OHMEDA S/5 ADU CARESTATION	Apr 30, 2009	Substantially Equivalent	GE Healthcare Finland Oy
K083098	NAVIGATOR APPLICATIONS SUITE	Apr 01, 2009	Substantially Equivalent	GE Healthcare Finland Oy
K090233	GE DATEX-OHMEDA AISYS	Mar 05, 2009	Substantially Equivalent	Datex-Ohmeda, Inc.
K083413	COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM	Dec 18, 2008	Substantially Equivalent	Philips Medical Systems
K081447	FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO	Oct 08, 2008	Substantially Equivalent	Draeger Medical AG & Co. KG
K081844	GE DATEX-OHMEDA AVANCE	Aug 29, 2008	Substantially Equivalent	Datex-Ohmeda, Inc.
K081941	NAVIGATOR APPLICATIONS SUITE	Aug 07, 2008	Substantially Equivalent	GE Healthcare Finland Oy
K072884	FABIUS MRI	Jul 30, 2008	Substantially Equivalent	Draeger Medical AG & Co. KG
K080175	NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01	Jun 09, 2008	Substantially Equivalent	Datascope Corp., Patient Monitoring Division
K073707	GE DATEX-OHMEDA AISYS	Jan 30, 2008	Substantially Equivalent	Datex-Ohmeda, Inc.
K072420	MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE	Jan 22, 2008	Substantially Equivalent	Oceanic Medical Products, Inc.
K071097	NAVIGATOR APPLICATIONS SUITE	Oct 10, 2007	Substantially Equivalent	GE Healthcare Finland Oy
K071142	GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM	Jun 06, 2007	Substantially Equivalent	Datex-Ohmeda
K062388	ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM	Feb 22, 2007	Substantially Equivalent	Docusys
K062155	DIGITAL MXR-D FLOWMETER	Nov 09, 2006	Substantially Equivalent	Porter Instrument Co., Inc.
K061102	PRIMA ANAESTHESIA MACHINE	Jul 28, 2006	Substantially Equivalent	Penlon , Ltd.
K061609	GE DATEX-OHMEDA AISYS	Jun 27, 2006	Substantially Equivalent	Datex-Ohmeda, Inc.
K060193	MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2	Apr 10, 2006	Substantially Equivalent	Oceanic Medical Products, Inc.
K052335	ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA	Nov 23, 2005	Substantially Equivalent	Accutron, Inc.
K050883	SAFERSLEEP SYSTEM	Nov 04, 2005	Substantially Equivalent	Safer Sleep, LLC
K051629	BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000	Sep 23, 2005	Substantially Equivalent	Blease USA, Inc.
K050676	GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)	Apr 12, 2005	Substantially Equivalent	Datex-Ohmeda, Inc.
K050626	GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM	Mar 25, 2005	Substantially Equivalent	Datex-Ohmeda, Inc.
K050055	GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM	Feb 04, 2005	Substantially Equivalent	Datex-Ohmeda, Inc.
K042607	PRIMUS US	Nov 26, 2004	Substantially Equivalent	Draeger Medical, Inc.
K042419	FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM	Oct 08, 2004	Substantially Equivalent	Draeger Medical, Inc.
K041430	BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000	Oct 07, 2004	Substantially Equivalent	Blease Medical Equipment , Ltd.
K033026	MALLARD MODEL 3000 ANESTHESIA MACHINE	Sep 03, 2004	Substantially Equivalent	Mallard Medical, Inc.
K042154	GE DATEX-OHMEDA AISYS CARESTATION	Aug 31, 2004	Substantially Equivalent	Datex-Ohmeda, Inc.
K042086	FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM	Aug 31, 2004	Substantially Equivalent	Draeger Medical, Inc.
K041622	MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM	Jul 08, 2004	Substantially Equivalent	Draeger Medical, Inc.
K033498	NARKOMED 6400, MODEL NM6400	Apr 26, 2004	Substantially Equivalent	Draeger Medical, Inc.
K040743	MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM	Apr 22, 2004	Substantially Equivalent	Datex-Ohmeda, Inc.
K030624	MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM	Mar 17, 2004	Substantially Equivalent	Draeger Medical, Inc.
K032803	DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM	Mar 10, 2004	Substantially Equivalent	Datex-Ohmeda
K031400	FABIUS TIRO ANESTHESIA SYSTEM	Jul 15, 2003	Substantially Equivalent	Draeger Medical, Inc.
K030939	PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE	Jul 15, 2003	Substantially Equivalent	Philips Medical Systems
K022031	NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2	Aug 29, 2002	Substantially Equivalent	Draeger Medical, Inc.
K011404	FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS	Feb 22, 2002	Substantially Equivalent	Draeger Medical, Inc.
K010613	MAGELLAN-2200, MODEL 1	Oct 12, 2001	Substantially Equivalent	Oceanic Medical Products, Inc.
K012446	OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI	Oct 03, 2001	Substantially Equivalent	Charles A. Smith
K003663	SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE	Jun 28, 2001	Substantially Equivalent	Spacelabs Medical, Inc.
K003251	BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690	May 23, 2001	Substantially Equivalent	Blease Medical Equipment , Ltd.
K001988	MODULAR	Feb 05, 2001	Substantially Equivalent	Heyer America, Inc.
K003579	NARKOMED MRI-2, MODEL NM-MRI-2	Jan 22, 2001	Substantially Equivalent	Draeger Medical, Inc.
K000995	NARKOMAT, MODEL 2000	Oct 11, 2000	Substantially Equivalent	Heyer America, Inc.
K000859	OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1	Aug 23, 2000	Substantially Equivalent	Charles A. Smith
K001727	MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES	Aug 09, 2000	Substantially Equivalent	Blease Medical Equipment , Ltd.
K001488	NARKOMED MRI , NM-MRI	Jun 09, 2000	Substantially Equivalent	Draeger Medical, Inc.
K001315	MODIFICATION TO KION ANESTHESIA SYSTEM	May 26, 2000	Substantially Equivalent	Siemens Elema AB
K000706	DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR	May 11, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K993410	DATES-OHMEDA AESTIVA SMARTVENT MRI	Apr 25, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K992421	GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076	Oct 27, 1999	Substantially Equivalent	Accutron, Inc.
K973971	KION ANESTHESIA SYSTEM	Sep 13, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K982137	BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE	Apr 09, 1999	Substantially Equivalent	Blease Medical Equipment , Ltd.
K983635	JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN	Jan 11, 1999	Substantially Equivalent	Draeger Medical, Inc.
K981530	SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM	Nov 20, 1998	Substantially Equivalent	Spacelabs Medical, Inc.
K981845	HAWK ANAESTHESIA INDUCTION UNIT	Nov 03, 1998	Substantially Equivalent	Medical Industrial Equipment
K973985	AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)	Oct 30, 1998	Substantially Equivalent	Datex-Engstrom, Inc.
K980553	NARKOMED 6000 MODEL NUMBER NM6000	Aug 04, 1998	Substantially Equivalent	Draeger Medical, Inc.
K973896	OHMEDA EXCEL 3000 ANESTHESIA SYSTEM	Apr 21, 1998	Substantially Equivalent	Ohmeda Medical
K973949	PERIOPERATIVE DATA MANAGEMENT SYSTEM	Feb 06, 1998	Substantially Equivalent	Draeger Medical, Inc.
K974193	NARKOMED ULTRASONIC FLOW SENSOR	Jan 28, 1998	Substantially Equivalent	Draeger Medical, Inc.
K970163	ALPHA MX (20)/ULTRA PC (30)	Dec 10, 1997	Substantially Equivalent	Technical Medical Products, Inc.
K971030	MIE FALCON, DATEX ENGSTROM FLEXIMA II	Nov 12, 1997	Substantially Equivalent	Medical and Industrial Equipment
K972848	NARKOMED MRI ANESTHESIA SYSTEM	Oct 30, 1997	Substantially Equivalent	Draeger Medical, Inc.
K965160	HP ORVUE INTRA-OP (M2510A)	Sep 11, 1997	Substantially Equivalent	Hewlett-Packard GmbH
K971425	NARKOMED M ANESTHESIA SYSTEM (M)	Sep 10, 1997	Substantially Equivalent	Draeger Medical, Inc.
K963481	ANODYNE CC	Aug 11, 1997	Substantially Equivalent	Heyer America, Inc.
K965041	OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM	Jun 17, 1997	Substantially Equivalent	Ohmeda Medical
K963994	NARKOMED GS ANESTHESIA SYSTEM	Mar 19, 1997	Substantially Equivalent	Draeger Medical, Inc.
K946127	OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM	Oct 08, 1996	Substantially Equivalent	Ohmeda Medical
K945463	PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM	Feb 03, 1995	Substantially Equivalent	Draeger Medical, Inc.
K945234	AS/3 MEMORY MODULE, M0MEM	Jan 27, 1995	Substantially Equivalent	Datex Division Instrumentarium Corp.
K945722	MATRX MDM, RA	Dec 29, 1994	Substantially Equivalent	Matrx Medical, Inc.
K933285	DATEX AS/3 TM ANAESTHESIA MONITOR	Nov 14, 1994	Substantially Equivalent	Datex Division Instrumentarium Corp.
K923172	ANAESTHESIA RECORD KEEPER	Aug 09, 1994	Substantially Equivalent	Datex Division Instrumentarium Corp.
K935546	MAC/IV SEDATION KIT	Jun 13, 1994	Unknown	Vital Signs, Inc.
K934669	ARC	Apr 26, 1994	Substantially Equivalent	Medelec , Ltd.
K930351	NARKOMED 2C ANESTHESIA SYSTEM	Jun 22, 1993	Substantially Equivalent	Draeger Medical, Inc.
K930492	IDACARE ANESTHESIA MANAGEMENT WORKSTATIN	Jun 18, 1993	Substantially Equivalent	Premier Anesthesia Systems
K925580	OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD	Jun 02, 1993	Substantially Equivalent	Ohmeda Anesthesia Systems Therapy Group
K921742	OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY	May 26, 1993	Substantially Equivalent	Ohmeda Medical
K913791	OHMEDA 7800 ANESTHESIA VENTILATOR	Apr 08, 1993	Substantially Equivalent	Ohmeda Anesthesia Systems Therapy Group
K923519	SENSOR GUI	Dec 08, 1992	Substantially Equivalent	Hospitronic
K920944	FTS-200 GAS SYSTEM	May 29, 1992	Substantially Equivalent	Trek Medical Products, Inc.
K905635	OHMEDA MODULUS CD ANESTHESIA SYSTEM	May 03, 1991	Substantially Equivalent	Ohmeda Medical
K903991	PCM ANESTHESIA	Feb 25, 1991	Substantially Equivalent	Siemens Life Support Systems
K903135	CLINI-CALC	Jan 14, 1991	Substantially Equivalent	Shasta Logic Corp.
K901117	OHMEDA UNIVERSAL PAC	Sep 07, 1990	Substantially Equivalent	Ohmeda Medical
K902962	LIFELOG(TM)	Sep 04, 1990	Substantially Equivalent	Modular Instruments, Inc.
K901713	NARKOMED 4 ANESTHESIA SYSTEM	Jul 09, 1990	Substantially Equivalent	Draeger Medical, Inc.
K901119	OHMEDA MODULUS CD ANESTHESIA SYSTEM	May 18, 1990	Substantially Equivalent	Ohmeda Medical
K893780	OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM	Apr 19, 1990	Substantially Equivalent	Ohmeda Medical
K900937	O.R. DATA MANAGER	Apr 05, 1990	Substantially Equivalent	Draeger Medical, Inc.
K900329	NARKOMED 3 ANESTHESIA SYSTEM	Feb 01, 1990	Substantially Equivalent	Draeger Medical, Inc.
K900328	NARKOMED 2B ANESTHESIA SYSTEM	Feb 01, 1990	Substantially Equivalent	Draeger Medical, Inc.
K894309	OHMEDA MODULUS CD ANESTHESIA SYSTEM	Oct 06, 1989	Substantially Equivalent	Ohmeda Medical
K884802	CAVENDISH 460/680 ANESTHESIA MACHINE	Aug 01, 1989	Substantially Equivalent	Dentsply Intl.
K884991	CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN	Jun 06, 1989	Substantially Equivalent	Datex Division Instrumentarium Corp.
K890410	REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE	Apr 12, 1989	Substantially Equivalent	Ohmeda Medical
K884879	CENTURION(TM) MIXER	Feb 09, 1989	Substantially Equivalent	Matrix Medica, Inc.
K882489	REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS	Jul 08, 1988	Substantially Equivalent	Ohmeda Medical
K875350	OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM	Mar 24, 1988	Substantially Equivalent	Ohmeda Medical
K872178	MODIFICATION TO ARKIVE(TM)	Jan 27, 1988	Substantially Equivalent	Diatek, Inc.
K864589	TRI-SERVICE OMV VAPORIZER	Jun 05, 1987	Substantially Equivalent	Bear Medical Systems, Inc.
K864590	AM1000	May 04, 1987	Substantially Equivalent	Bear Medical Systems, Inc.
K864644	PHOENIX-C ANESTHESIA MACHINE	Mar 09, 1987	Substantially Equivalent	American Anesthesia, Inc.
K864447	NARKOMED 2B ANESTHESIA SYSTEM	Jan 27, 1987	Substantially Equivalent	Draeger Medical, Inc.
K864806	ANESTHESIA RECORDER	Jan 15, 1987	Substantially Equivalent	Draeger Medical, Inc.
K862085	ARKIVE (TM)	Jan 12, 1987	Substantially Equivalent	Diatek, Inc.
K863207	OHMEDA 'B' SERIES GAS DELIVERY SYSTEM	Oct 30, 1986	Substantially Equivalent	Ohmeda Medical
K862831	MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM	Aug 20, 1986	Substantially Equivalent	Ohmeda Medical
K861170	NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)	Apr 01, 1986	Substantially Equivalent	Draeger Medical, Inc.
K855022	COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK	Feb 28, 1986	Substantially Equivalent	Computerized Anesthesia Systems, Inc.
K853435	NARKOMED 3 ANESTHESIA SYSTEM	Jan 22, 1986	Substantially Equivalent	Draeger Medical, Inc.
K854213	ARI STANDARD ANESTHESIA RECORD	Dec 19, 1985	Substantially Equivalent	Agilent Technologies, Inc.
K852175	PATIENT DATA SYSTEMS CVA	Sep 06, 1985	Substantially Equivalent	Patient Data Systems
K853139	PHOENIX ANESTHESIA MACHINE	Aug 26, 1985	Substantially Equivalent	American Anesthesia, Inc.
K850648	OHMEDA PAC PORTABLE ANESTHESIA SYSTEM	Jul 01, 1985	Substantially Equivalent	Ohmeda Medical
K844563	PHOENIX ANESTHESIA MACHINE	Jun 14, 1985	Substantially Equivalent	American Anesthesia, Inc.
K844849	OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA	May 15, 1985	Substantially Equivalent	Ohmeda Medical
K851621	BOOM ARM	May 10, 1985	Substantially Equivalent	Draeger Medical, Inc.
K844008	PENLON AM1000 ANAESTHESIA MACHINE	Mar 12, 1985	Substantially Equivalent	Penlon, Inc.
K844421	FOREGGER DOME VALVES	Jan 14, 1985	Substantially Equivalent	Puritan Bennett Corp.
K844012	OHMEDA ANESTHESIA RECORD KEEPER	Oct 18, 1984	Substantially Equivalent	Ohmeda Medical
K841370	KMA-1300F	Jun 07, 1984	Substantially Equivalent	Medimex, Inc.
K840356	OHIO UNITROL II ANESTHESIA GAS MACHINE	Apr 20, 1984	Substantially Equivalent	Ohio Medical Products
K841274	BAG-TO-VENTILATOR SELECTOR VALVE	Apr 13, 1984	Substantially Equivalent	Ohio Medical Products
K833147	CENTRALERT	Dec 16, 1983	Substantially Equivalent	Draeger Medical, Inc.
K833335	MODULUS II ANESTHESIA GAS MACHINE	Nov 14, 1983	Substantially Equivalent	Ohio Medical Products
K833151	BOYLE SYSTEM ANESTHESIA GAS MACHINE	Nov 14, 1983	Substantially Equivalent	Fraser Harlake, Inc.
K830680	AIR-SHIELDS VENTIMETER VENTILATOR-CONTR	Apr 08, 1983	Substantially Equivalent	Narco Scientific
K830161	ANESTHESIA APATATUS #D-25	Mar 09, 1983	Substantially Equivalent	W.E. Leder Enterprises, Inc.
K830160	ANESTHESIA APPARATUS #FO 20S	Mar 09, 1983	Substantially Equivalent	W.E. Leder Enterprises, Inc.
K830159	ANESTHESIA APPARATUS PH-35	Mar 09, 1983	Substantially Equivalent	W.E. Leder Enterprises, Inc.
K822218	NARKOMED 2A ANESTHESIA MACHINE	Sep 07, 1982	Substantially Equivalent	Draeger Medical, Inc.
K803052	NUFFIELD ANESTHESIA VENTILATOR SER. 400	Jan 07, 1981	Substantially Equivalent	Penlon, Inc.
K802591	MODEL 5460 + 5480 POP-OFF VALVES	Nov 12, 1980	Substantially Equivalent	G. Dundas Co.
K801102	COMPALOR-ORAL SURGERY MODEL	Jun 17, 1980	Substantially Equivalent	Narco Mckesson Co.
K801103	COMPALOR-DENTAL MODEL	May 28, 1980	Substantially Equivalent	Narco Mckesson Co.
K801100	ANALOR FOUR-DENTAL MODEL	May 28, 1980	Substantially Equivalent	Narco Mckesson Co.
K800801	ANALGESIA UNITS, OXYGEN & NITRATE DEVICE	May 28, 1980	Substantially Equivalent	Spica, Inc.
K791530	OHIO MODULAR ANESTHESIA GAS MACHINE	Sep 19, 1979	Substantially Equivalent	Ohio Medical Products
K790456	SERIES 7000	Mar 23, 1979	Substantially Equivalent	Narco Mckesson Co.
K781492	SERIES 7000 GAS MACHINE	Sep 11, 1978	Substantially Equivalent	Narco Mckesson Co.
K771989	CONTINUOUS FLOW ANESTHESIA MACHINE	Nov 15, 1977	Substantially Equivalent	Draeger Medical, Inc.
K771479	NITROX 30 - ANESTHETIC GAS PROPORTIONER	Nov 07, 1977	Substantially Equivalent	Ohio Medical Products
K771057	ANESTHESIA MACHINE	Jul 05, 1977	Substantially Equivalent	Foregger
K770554	NARKOMED ANESTHESIA MACHINE	Mar 30, 1977	Substantially Equivalent	Draeger Medical, Inc.
K760228	ANESTHESIA MACHINE, CHEMETRON	Aug 06, 1976	Substantially Equivalent	Chemetron Health Systems