Gas-Machine, Anesthesia
FDA product code BSZ · 181 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5160
- Review panel
- AN
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-08-06 – 2026-06-25
BSZ
2026-06-25
BSZ
2026-05-21
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
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BSZ
2025-07-11
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)
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BSZ
2023-07-23
Atlan
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BSZ
2023-03-28
Carestation 750/750c
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BSZ
2021-03-26
A8, A9 Anesthesia System
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BSZ
2020-03-18
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
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BSZ
2018-01-12
A5 Anesthesia System
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BSZ
2018-01-12
A7 Anesthesia System
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BSZ
2017-11-03
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
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BSZ
2017-08-15
Aisys CS2
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BSZ
2017-03-29
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
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BSZ
2016-01-21
Carestation 620/650/650C
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BSZ
2013-12-20
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
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BSZ
2013-08-08
GE DATEX-OHMEDA AVANCE CS2
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BSZ
2013-08-02
INTELLISAVE AX700 ANESTHESIA SYSTEM
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BSZ
2013-02-14
A5 ANESTHESIA DELIVERY SYSTEM
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BSZ
2013-02-06
GE DATEX-OHMEDA AVANCE CS2
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BSZ
2012-10-12
AESPIRE 7900, AESPIRE VIEW
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BSZ
2012-04-20
MCKESSON ANESTHESIA CARE
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BSZ
2012-03-28
SMARTPILOT VIEW MODEL MK04500
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BSZ
2012-01-26
AM-6000 ANESTHESIA MACHINE
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BSZ
2012-01-13
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
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BSZ
2011-12-16
GE DATEX-OHMEDA AVANCE
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BSZ
2011-07-20
GE DATEX-OHMEDA AISYS
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BSZ
2011-06-10
NAVIGATOR APPLICATIONS SUITE
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BSZ
2011-05-09
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
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BSZ
2011-02-11
AS3700 ANESTHSIA DELIVERY SYSTEM
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BSZ
2011-02-07
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
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BSZ
2010-01-12
AESPIRE 7900, AESPIRE VIEW
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BSZ
2009-04-30
GE DATEX-OHMEDA S/5 ADU CARESTATION
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BSZ
2009-04-01
NAVIGATOR APPLICATIONS SUITE
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BSZ
2009-03-05
GE DATEX-OHMEDA AISYS
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BSZ
2008-12-18
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
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BSZ
2008-10-08
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
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BSZ
2008-08-29
GE DATEX-OHMEDA AVANCE
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BSZ
2008-08-07
NAVIGATOR APPLICATIONS SUITE
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BSZ
2008-07-30
FABIUS MRI
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BSZ
2008-06-09
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
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BSZ
2008-01-30
GE DATEX-OHMEDA AISYS
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BSZ
2008-01-22
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
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BSZ
2007-10-10
NAVIGATOR APPLICATIONS SUITE
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BSZ
2007-06-06
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
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BSZ
2007-02-22
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
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BSZ
2006-11-09
DIGITAL MXR-D FLOWMETER
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BSZ
2006-07-28
PRIMA ANAESTHESIA MACHINE
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BSZ
2006-06-27
GE DATEX-OHMEDA AISYS
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BSZ
2006-04-10
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
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BSZ
2005-11-23
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
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BSZ
2005-11-04
SAFERSLEEP SYSTEM
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BSZ
2005-09-23
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
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BSZ
2005-04-12
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
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BSZ
2005-03-25
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
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BSZ
2005-02-04
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
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BSZ
2004-11-26
PRIMUS US
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BSZ
2004-10-08
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
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BSZ
2004-10-07
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
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BSZ
2004-09-03
MALLARD MODEL 3000 ANESTHESIA MACHINE
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BSZ
2004-08-31
GE DATEX-OHMEDA AISYS CARESTATION
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BSZ
2004-08-31
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
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BSZ
2004-07-08
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
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BSZ
2004-04-26
NARKOMED 6400, MODEL NM6400
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BSZ
2004-04-22
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
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BSZ
2004-03-17
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
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BSZ
2004-03-10
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
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BSZ
2003-07-15
FABIUS TIRO ANESTHESIA SYSTEM
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BSZ
2003-07-15
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
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BSZ
2002-08-29
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
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BSZ
2002-02-22
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
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BSZ
2001-10-12
MAGELLAN-2200, MODEL 1
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BSZ
2001-10-03
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
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BSZ
2001-06-28
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
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BSZ
2001-05-23
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
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BSZ
2001-02-05
MODULAR
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BSZ
2001-01-22
NARKOMED MRI-2, MODEL NM-MRI-2
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BSZ
2000-10-11
NARKOMAT, MODEL 2000
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BSZ
2000-08-23
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
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BSZ
2000-08-09
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
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BSZ
2000-06-09
NARKOMED MRI , NM-MRI
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BSZ
2000-05-26
MODIFICATION TO KION ANESTHESIA SYSTEM
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BSZ
2000-05-11
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
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BSZ
2000-04-25
DATES-OHMEDA AESTIVA SMARTVENT MRI
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BSZ
1999-10-27
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
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BSZ
1999-09-13
KION ANESTHESIA SYSTEM
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BSZ
1999-04-09
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
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BSZ
1999-01-11
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
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BSZ
1998-11-20
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
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BSZ
1998-11-03
HAWK ANAESTHESIA INDUCTION UNIT
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BSZ
1998-10-30
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
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BSZ
1998-08-04
NARKOMED 6000 MODEL NUMBER NM6000
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BSZ
1998-04-21
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
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BSZ
1998-02-06
PERIOPERATIVE DATA MANAGEMENT SYSTEM
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BSZ
1998-01-28
NARKOMED ULTRASONIC FLOW SENSOR
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BSZ
1997-12-10
ALPHA MX (20)/ULTRA PC (30)
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BSZ
1997-11-12
MIE FALCON, DATEX ENGSTROM FLEXIMA II
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BSZ
1997-10-30
NARKOMED MRI ANESTHESIA SYSTEM
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BSZ
1997-09-11
HP ORVUE INTRA-OP (M2510A)
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BSZ
1997-09-10
NARKOMED M ANESTHESIA SYSTEM (M)
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BSZ
1997-08-11
ANODYNE CC
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BSZ
1997-06-17
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
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