BSZ · Gas-Machine, Anesthesia
Anesthesiology · 21 CFR 868.5160 · Class 2
Overview
| Product Code | BSZ |
|---|---|
| Device Name | Gas-Machine, Anesthesia |
| Regulation | 21 CFR 868.5160 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).
Classification Rationale
Class II (performance standards).
Cleared Devices (187)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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) | Codonics.Incorporated | Jul 11, 2025 | SESE |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | Jul 23, 2023 | SESE |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | Mar 28, 2023 | SESE |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Mar 26, 2021 | SESE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | Mar 18, 2020 | SESE |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 12, 2018 | SESE |
| K172045 | 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. | Nov 3, 2017 | SESE |
| K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | Aug 15, 2017 | SESE |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | Mar 29, 2017 | SESE |
| K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | Jan 21, 2016 | SESE |
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 27, 2015 | SESE |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | Apr 24, 2015 | SESE |
| K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jan 23, 2015 | SESE |
| K140264 | MADM | Thornhill Research, Inc. | Jan 5, 2015 | SESE |
| K132903 | DRE VENTURA | Dre Medical, Inc. | Jul 1, 2014 | SESE |
| K133886 | PERSEUS A500 | Draeger Medical GmbH | Jun 20, 2014 | SESE |
| K131790 | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | May 9, 2014 | SESE |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | Mar 20, 2014 | SESE |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Datex-Ohmeda, Inc. | Dec 20, 2013 | SESE |
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda | Aug 8, 2013 | SESE |
| K122063 | INTELLISAVE AX700 ANESTHESIA SYSTEM | Philips Anesthesia Care | Aug 2, 2013 | SESE |
| K123211 | A5 ANESTHESIA DELIVERY SYSTEM | Datascope Corp., Patient Monitoring Division | Feb 14, 2013 | SESE |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda, Inc. | Feb 6, 2013 | SESE |
| K122445 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda | Oct 12, 2012 | SESE |
| K113633 | MCKESSON ANESTHESIA CARE | Mckesson Technologies, Inc. | Apr 20, 2012 | SESE |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | Draeger Medical GmbH | Mar 28, 2012 | SESE |
| K120075 | AM-6000 ANESTHESIA MACHINE | Advanced Instrumentations, Inc. | Jan 26, 2012 | SESE |
| K112114 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 | Maquet Critical Care AB | Jan 13, 2012 | SESE |
| K112722 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | Dec 16, 2011 | SESE |
| K110213 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | Jul 20, 2011 | SESE |
| K102389 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | Jun 10, 2011 | SESE |
| K102182 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 | Maquet Critical Care AB | May 9, 2011 | SESE |
| K102471 | AS3700 ANESTHSIA DELIVERY SYSTEM | Mindray DS USA, Inc. | Feb 11, 2011 | SESE |
| K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | Codonics, Inc. | Feb 7, 2011 | SESE |
| K092864 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda Inc., A Division of Instrumentarium C | Jan 12, 2010 | SESE |
| K090892 | GE DATEX-OHMEDA S/5 ADU CARESTATION | GE Healthcare Finland Oy | Apr 30, 2009 | SESE |
| K083098 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | Apr 1, 2009 | SESE |
| K090233 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | Mar 5, 2009 | SESE |
| K083413 | COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM | Philips Medical Systems | Dec 18, 2008 | SESE |
| K081447 | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO | Draeger Medical AG & Co. KG | Oct 8, 2008 | SESE |
| K081844 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | Aug 29, 2008 | SESE |
| K081941 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | Aug 7, 2008 | SESE |
| K072884 | FABIUS MRI | Draeger Medical AG & Co. KG | Jul 30, 2008 | SESE |
| K080175 | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | Jun 9, 2008 | SESE |
| K073707 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | Jan 30, 2008 | SESE |
| K072420 | MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE | Oceanic Medical Products, Inc. | Jan 22, 2008 | SESE |
| K071097 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | Oct 10, 2007 | SESE |
| K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda | Jun 6, 2007 | SESE |
| K062388 | ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM | Docusys | Feb 22, 2007 | SESE |
| K062155 | DIGITAL MXR-D FLOWMETER | Porter Instrument Co., Inc. | Nov 9, 2006 | SESE |
| K061102 | PRIMA ANAESTHESIA MACHINE | Penlon , Ltd. | Jul 28, 2006 | SESE |
| K061609 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | Jun 27, 2006 | SESE |
| K060193 | MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 | Oceanic Medical Products, Inc. | Apr 10, 2006 | SESE |
| K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA | Accutron, Inc. | Nov 23, 2005 | SESE |
| K050883 | SAFERSLEEP SYSTEM | Safer Sleep, LLC | Nov 4, 2005 | SESE |
| K051629 | BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 | Blease USA, Inc. | Sep 23, 2005 | SESE |
| K050676 | GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) | Datex-Ohmeda, Inc. | Apr 12, 2005 | SESE |
| K050626 | GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | Mar 25, 2005 | SESE |
| K050055 | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | Feb 4, 2005 | SESE |
| K042607 | PRIMUS US | Draeger Medical, Inc. | Nov 26, 2004 | SESE |
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | Oct 8, 2004 | SESE |
| K041430 | BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 | Blease Medical Equipment , Ltd. | Oct 7, 2004 | SESE |
| K033026 | MALLARD MODEL 3000 ANESTHESIA MACHINE | Mallard Medical, Inc. | Sep 3, 2004 | SESE |
| K042154 | GE DATEX-OHMEDA AISYS CARESTATION | Datex-Ohmeda, Inc. | Aug 31, 2004 | SESE |
| K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | Aug 31, 2004 | SESE |
| K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | Jul 8, 2004 | SESE |
| K033498 | NARKOMED 6400, MODEL NM6400 | Draeger Medical, Inc. | Apr 26, 2004 | SESE |
| K040743 | MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | Apr 22, 2004 | SESE |
| K030624 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM | Draeger Medical, Inc. | Mar 17, 2004 | SESE |
| K032803 | DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda | Mar 10, 2004 | SESE |
| K031400 | FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | Jul 15, 2003 | SESE |
| K030939 | PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE | Philips Medical Systems | Jul 15, 2003 | SESE |
| K022031 | NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 | Draeger Medical, Inc. | Aug 29, 2002 | SESE |
| K011404 | FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS | Draeger Medical, Inc. | Feb 22, 2002 | SESE |
| K010613 | MAGELLAN-2200, MODEL 1 | Oceanic Medical Products, Inc. | Oct 12, 2001 | SESE |
| K012446 | OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI | Charles A. Smith | Oct 3, 2001 | SESE |
| K003663 | SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE | Spacelabs Medical, Inc. | Jun 28, 2001 | SESE |
| K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 | Blease Medical Equipment , Ltd. | May 23, 2001 | SESE |
| K001988 | MODULAR | Heyer America, Inc. | Feb 5, 2001 | SESE |
| K003579 | NARKOMED MRI-2, MODEL NM-MRI-2 | Draeger Medical, Inc. | Jan 22, 2001 | SESE |
| K000995 | NARKOMAT, MODEL 2000 | Heyer America, Inc. | Oct 11, 2000 | SESE |
| K000859 | OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 | Charles A. Smith | Aug 23, 2000 | SESE |
| K001727 | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES | Blease Medical Equipment , Ltd. | Aug 9, 2000 | SESE |
| K001488 | NARKOMED MRI , NM-MRI | Draeger Medical, Inc. | Jun 9, 2000 | SESE |
| K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM | Siemens Elema AB | May 26, 2000 | SESE |
| K000706 | DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR | Datex-Ohmeda, Inc. | May 11, 2000 | SESE |
| K993410 | DATES-OHMEDA AESTIVA SMARTVENT MRI | Datex-Ohmeda, Inc. | Apr 25, 2000 | SESE |
| K992421 | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 | Accutron, Inc. | Oct 27, 1999 | SESE |
| K973971 | KION ANESTHESIA SYSTEM | Siemens Medical Solutions USA, Inc. | Sep 13, 1999 | SESE |
| K982137 | BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE | Blease Medical Equipment , Ltd. | Apr 9, 1999 | SESE |
| K983635 | JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN | Draeger Medical, Inc. | Jan 11, 1999 | SESE |
| K981530 | SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM | Spacelabs Medical, Inc. | Nov 20, 1998 | SESE |
| K981845 | HAWK ANAESTHESIA INDUCTION UNIT | Medical Industrial Equipment | Nov 3, 1998 | SESE |
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) | Datex-Engstrom, Inc. | Oct 30, 1998 | SESE |
| K980553 | NARKOMED 6000 MODEL NUMBER NM6000 | Draeger Medical, Inc. | Aug 4, 1998 | SESE |
| K973896 | OHMEDA EXCEL 3000 ANESTHESIA SYSTEM | Ohmeda Medical | Apr 21, 1998 | SESE |
| K973949 | PERIOPERATIVE DATA MANAGEMENT SYSTEM | Draeger Medical, Inc. | Feb 6, 1998 | SESE |
| K974193 | NARKOMED ULTRASONIC FLOW SENSOR | Draeger Medical, Inc. | Jan 28, 1998 | SESE |
| K970163 | ALPHA MX (20)/ULTRA PC (30) | Technical Medical Products, Inc. | Dec 10, 1997 | SESE |
| K971030 | MIE FALCON, DATEX ENGSTROM FLEXIMA II | Medical and Industrial Equipment | Nov 12, 1997 | SESE |
| K972848 | NARKOMED MRI ANESTHESIA SYSTEM | Draeger Medical, Inc. | Oct 30, 1997 | SESE |
| K965160 | HP ORVUE INTRA-OP (M2510A) | Hewlett-Packard GmbH | Sep 11, 1997 | SESE |
| K971425 | NARKOMED M ANESTHESIA SYSTEM (M) | Draeger Medical, Inc. | Sep 10, 1997 | SESE |
| K963481 | ANODYNE CC | Heyer America, Inc. | Aug 11, 1997 | SESE |
| K965041 | OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM | Ohmeda Medical | Jun 17, 1997 | SESE |
| K963994 | NARKOMED GS ANESTHESIA SYSTEM | Draeger Medical, Inc. | Mar 19, 1997 | SESE |
| K946127 | OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM | Ohmeda Medical | Oct 8, 1996 | SESE |
| K945463 | PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM | Draeger Medical, Inc. | Feb 3, 1995 | SESE |
| K945234 | AS/3 MEMORY MODULE, M0MEM | Datex Division Instrumentarium Corp. | Jan 27, 1995 | SESE |
| K945722 | MATRX MDM, RA | Matrx Medical, Inc. | Dec 29, 1994 | SESE |
| K933285 | DATEX AS/3 TM ANAESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Nov 14, 1994 | SESE |
| K923172 | ANAESTHESIA RECORD KEEPER | Datex Division Instrumentarium Corp. | Aug 9, 1994 | SESE |
| K935546 | MAC/IV SEDATION KIT | Vital Signs, Inc. | Jun 13, 1994 | SEKD |
| K934669 | ARC | Medelec , Ltd. | Apr 26, 1994 | SESE |
| K930351 | NARKOMED 2C ANESTHESIA SYSTEM | Draeger Medical, Inc. | Jun 22, 1993 | SESE |
| K930492 | IDACARE ANESTHESIA MANAGEMENT WORKSTATIN | Premier Anesthesia Systems | Jun 18, 1993 | SESE |
| K925580 | OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD | Ohmeda Anesthesia Systems Therapy Group | Jun 2, 1993 | SESE |
| K921742 | OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY | Ohmeda Medical | May 26, 1993 | SESE |
| K913791 | OHMEDA 7800 ANESTHESIA VENTILATOR | Ohmeda Anesthesia Systems Therapy Group | Apr 8, 1993 | SESE |
| K923519 | SENSOR GUI | Hospitronic | Dec 8, 1992 | SESE |
| K920944 | FTS-200 GAS SYSTEM | Trek Medical Products, Inc. | May 29, 1992 | SESE |
| K905635 | OHMEDA MODULUS CD ANESTHESIA SYSTEM | Ohmeda Medical | May 3, 1991 | SESE |
| K903991 | PCM ANESTHESIA | Siemens Life Support Systems | Feb 25, 1991 | SESE |
| K903135 | CLINI-CALC | Shasta Logic Corp. | Jan 14, 1991 | SESE |
| K901117 | OHMEDA UNIVERSAL PAC | Ohmeda Medical | Sep 7, 1990 | SESE |
| K902962 | LIFELOG(TM) | Modular Instruments, Inc. | Sep 4, 1990 | SESE |
| K901713 | NARKOMED 4 ANESTHESIA SYSTEM | Draeger Medical, Inc. | Jul 9, 1990 | SESE |
| K901119 | OHMEDA MODULUS CD ANESTHESIA SYSTEM | Ohmeda Medical | May 18, 1990 | SESE |
| K893780 | OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM | Ohmeda Medical | Apr 19, 1990 | SESE |
| K900937 | O.R. DATA MANAGER | Draeger Medical, Inc. | Apr 5, 1990 | SESE |
| K900329 | NARKOMED 3 ANESTHESIA SYSTEM | Draeger Medical, Inc. | Feb 1, 1990 | SESE |
| K900328 | NARKOMED 2B ANESTHESIA SYSTEM | Draeger Medical, Inc. | Feb 1, 1990 | SESE |
| K894309 | OHMEDA MODULUS CD ANESTHESIA SYSTEM | Ohmeda Medical | Oct 6, 1989 | SESE |
| K884802 | CAVENDISH 460/680 ANESTHESIA MACHINE | Dentsply Intl. | Aug 1, 1989 | SESE |
| K884991 | CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN | Datex Division Instrumentarium Corp. | Jun 6, 1989 | SESE |
| K890410 | REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE | Ohmeda Medical | Apr 12, 1989 | SESE |
| K884879 | CENTURION(TM) MIXER | Matrix Medica, Inc. | Feb 9, 1989 | SESE |
| K882489 | REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS | Ohmeda Medical | Jul 8, 1988 | SESE |
| K875350 | OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM | Ohmeda Medical | Mar 24, 1988 | SESE |
| K872178 | MODIFICATION TO ARKIVE(TM) | Diatek, Inc. | Jan 27, 1988 | SESE |
| K864589 | TRI-SERVICE OMV VAPORIZER | Bear Medical Systems, Inc. | Jun 5, 1987 | SESE |
| K864590 | AM1000 | Bear Medical Systems, Inc. | May 4, 1987 | SESE |
| K864644 | PHOENIX-C ANESTHESIA MACHINE | American Anesthesia, Inc. | Mar 9, 1987 | SESE |
| K864447 | NARKOMED 2B ANESTHESIA SYSTEM | Draeger Medical, Inc. | Jan 27, 1987 | SESE |
| K864806 | ANESTHESIA RECORDER | Draeger Medical, Inc. | Jan 15, 1987 | SESE |
| K862085 | ARKIVE (TM) | Diatek, Inc. | Jan 12, 1987 | SESE |
| K863207 | OHMEDA 'B' SERIES GAS DELIVERY SYSTEM | Ohmeda Medical | Oct 30, 1986 | SESE |
| K862831 | MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM | Ohmeda Medical | Aug 20, 1986 | SESE |
| K861170 | NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED) | Draeger Medical, Inc. | Apr 1, 1986 | SESE |
| K855022 | COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK | Computerized Anesthesia Systems, Inc. | Feb 28, 1986 | SESE |
| K853435 | NARKOMED 3 ANESTHESIA SYSTEM | Draeger Medical, Inc. | Jan 22, 1986 | SESE |
| K854213 | ARI STANDARD ANESTHESIA RECORD | Agilent Technologies, Inc. | Dec 19, 1985 | SESE |
| K852175 | PATIENT DATA SYSTEMS CVA | Patient Data Systems | Sep 6, 1985 | SESE |
| K853139 | PHOENIX ANESTHESIA MACHINE | American Anesthesia, Inc. | Aug 26, 1985 | SESE |
| K850648 | OHMEDA PAC PORTABLE ANESTHESIA SYSTEM | Ohmeda Medical | Jul 1, 1985 | SESE |
| K844563 | PHOENIX ANESTHESIA MACHINE | American Anesthesia, Inc. | Jun 14, 1985 | SESE |
| K844849 | OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA | Ohmeda Medical | May 15, 1985 | SESE |
| K851621 | BOOM ARM | Draeger Medical, Inc. | May 10, 1985 | SESE |
| K844008 | PENLON AM1000 ANAESTHESIA MACHINE | Penlon, Inc. | Mar 12, 1985 | SESE |
| K844421 | FOREGGER DOME VALVES | Puritan Bennett Corp. | Jan 14, 1985 | SESE |
| K844012 | OHMEDA ANESTHESIA RECORD KEEPER | Ohmeda Medical | Oct 18, 1984 | SESE |
| K841370 | KMA-1300F | Medimex, Inc. | Jun 7, 1984 | SESE |
| K840356 | OHIO UNITROL II ANESTHESIA GAS MACHINE | Ohio Medical Products | Apr 20, 1984 | SESE |
| K841274 | BAG-TO-VENTILATOR SELECTOR VALVE | Ohio Medical Products | Apr 13, 1984 | SESE |
| K833147 | CENTRALERT | Draeger Medical, Inc. | Dec 16, 1983 | SESE |
| K833335 | MODULUS II ANESTHESIA GAS MACHINE | Ohio Medical Products | Nov 14, 1983 | SESE |
| K833151 | BOYLE SYSTEM ANESTHESIA GAS MACHINE | Fraser Harlake, Inc. | Nov 14, 1983 | SESE |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | Narco Scientific | Apr 8, 1983 | SESE |
| K830161 | ANESTHESIA APATATUS #D-25 | W.E. Leder Enterprises, Inc. | Mar 9, 1983 | SESE |
| K830160 | ANESTHESIA APPARATUS #FO 20S | W.E. Leder Enterprises, Inc. | Mar 9, 1983 | SESE |
| K830159 | ANESTHESIA APPARATUS PH-35 | W.E. Leder Enterprises, Inc. | Mar 9, 1983 | SESE |
| K822218 | NARKOMED 2A ANESTHESIA MACHINE | Draeger Medical, Inc. | Sep 7, 1982 | SESE |
| K803052 | NUFFIELD ANESTHESIA VENTILATOR SER. 400 | Penlon, Inc. | Jan 7, 1981 | SESE |
| K802591 | MODEL 5460 + 5480 POP-OFF VALVES | G. Dundas Co. | Nov 12, 1980 | SESE |
| K801102 | COMPALOR-ORAL SURGERY MODEL | Narco Mckesson Co. | Jun 17, 1980 | SESE |
| K801103 | COMPALOR-DENTAL MODEL | Narco Mckesson Co. | May 28, 1980 | SESE |
| K801100 | ANALOR FOUR-DENTAL MODEL | Narco Mckesson Co. | May 28, 1980 | SESE |
| K800801 | ANALGESIA UNITS, OXYGEN & NITRATE DEVICE | Spica, Inc. | May 28, 1980 | SESE |
| K791530 | OHIO MODULAR ANESTHESIA GAS MACHINE | Ohio Medical Products | Sep 19, 1979 | SESE |
| K790456 | SERIES 7000 | Narco Mckesson Co. | Mar 23, 1979 | SESE |
| K781492 | SERIES 7000 GAS MACHINE | Narco Mckesson Co. | Sep 11, 1978 | SESE |
| K771989 | CONTINUOUS FLOW ANESTHESIA MACHINE | Draeger Medical, Inc. | Nov 15, 1977 | SESE |
| K771479 | NITROX 30 - ANESTHETIC GAS PROPORTIONER | Ohio Medical Products | Nov 7, 1977 | SESE |
| K771057 | ANESTHESIA MACHINE | Foregger | Jul 5, 1977 | SESE |
| K770554 | NARKOMED ANESTHESIA MACHINE | Draeger Medical, Inc. | Mar 30, 1977 | SESE |
| K760228 | ANESTHESIA MACHINE, CHEMETRON | Chemetron Health Systems | Aug 6, 1976 | SESE |
Top Applicants
- Draeger Medical, Inc. — 33 clearances
- Datex-Ohmeda, Inc. — 20 clearances
- Ohmeda Medical — 17 clearances
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — 5 clearances
- Ohio Medical Products — 5 clearances
