Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2112667

FEI Number

2112667

Entity Name

Datex-Ohmeda, Inc.

City/State/Country

MADISON, WI, US

Establishment Address

3030 Ohmeda Drive, MADISON, WI 53718, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172045

PMA Number

N/A

All Registered Proprietary Names

Tec 6 Continuous Flow Vaporizer Tec 6 NAD Tec 6 Tec 6 Vaporizer Tec 6 Continuous Flow Vaporizer Tec 6 Tec 6 Vaporizer Tec 6 NAD iVent Circuits Gas exhaust line, white conical, disposable, 2m/6.6 ft, 5514184 Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in, 5514183 Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft, 5514182 Tec 7 Anesthesia Vaporizer Avance CS2 Avance CS2 Carestation GE Datex-Ohmeda Aisys CS2 Anesthesia System Aisys CS2 Carestation Enhanced Aladin Cassette ALADIN2 DES FIXED-FIL ALADIN2 SEV QUIK-FIL ALADIN2 SEV EASY-FIL ALADIN2 DES SAF-FIL ALADIN2 ISO EASY-FIL Aladin2 ALADIN2 SEV EASY-FIL A EAC ALADIN2 DES SAF-FIL B Aisys CS2 ALADIN2 SEV QUIK-FIL A ALADIN2 ENF-EASY-FIL ALADIN2 SEV EASY-FIL B Aisys CS2 with Et Control Aisys Aisys CS2 Amingo GE DATEX-OHMEDA ENGSTROM CARESTATION Evair Engstrom Carestation Avance CS2 Avance CS2 Anesthesia System Avance CS2 Carestation GE Datex-Ohmeda Avance CS2 Anesthesia System EAC Aisys Aladin2 Enhanced Aladin Cassette Aisys Carestation GE Datex-Ohmeda Aespire 7900 S/5 Aespire 7900 Aespire 7900 CARESCAPE R860 Ventilator R860 CARESCAPE R860 Tec 850 Tec 820 ISO Tec 850 ISO Tec 820 Tec 800 series Tec 850 SEV Tec 820 SEV Tec 8 Aestiva MRI Aestiva/5 MRI 2VAP W/ARTICULATING ARM Aestiva/5 7900 Aestiva/5 with 7900 Ventilator Aestiva 7900 Datex-Ohmeda Aestiva/5 GE Datex-Ohmeda Aestiva 7900 AESTIVA GOLDSEAL 3VAP W/ARTICULATING ARM GE Datex-Ohmeda Aestiva/5 7900 Anesthesia System Datex-Ohmeda Aestiva/5 7900 Anesthesia System Engstrom Carestation Aisys Aisys Carestation DATEX-OHMEDA ANESTHESIA VAPORIZER MODEL D-TEC Aisys Aisys Carestation Engstrom Carestation Engstom Pro Engstrom Carestation ENGSTROM PRO Ventilators GE Datex-Ohmeda ENGSTROM CARESTATION Engstrom Pro Aespire 7100/100 DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER Aespire View Tec 6 Plus Anesthesia Vaporizer S/5 Avance S/5 Avance Carestation Avance Carestation Avance Avance CS CARESCAPE R860 S/5 Avance Anesthesia System Avance CS2 Avance CS2 Pro Aestiva MRI 7100 Ventilator GE Datex-Ohmeda Aisys CS2 Anesthesia System Aestiva/5 MRI Aespire 100; Avance CS2 Anesthesia System S/5 Aespire 7100 GE Datex-Ohmeda Aestiva/5 7900 Anesthesia System Avance CS2 Carestation Aisys CS2 Carestation Datex-Ohmeda Aestiva/5 with 7100 Ventilator S/5 Aespire with 7900 Ventilator GE Datex Ohmeda Aespire 7900 Avance CS Avance S/5 Aespire 7900 S/5 Aespire Aespire 7100 Aisys Aestiva/5 Compact 2VAP W/ARTICULATING ARM Aestiva/5 7100 3VAP W/ARTICULATING ARM Aisys CS2 AESTIVA GOLDSEAL GE Datex-Ohmeda Avance CS2 Anesthesia System Aespire View Avance Anesthesia System Aisys Carestation Aestiva/5 7900 Aestiva 7100 Compact GE Datex-Ohmeda Aestiva 7900 S/5 Avance Aespire 7900 Datex-Ohmeda Aestiva/5 Aespire 7100/100 Avance Carestation Aestiva 7900 S/5 Avance Carestation Datex-Ohmeda Aestiva/5 7900 Anesthesia System GE Datex-Ohmeda Aestiva/5 Aisys CS2 with Et Control GE Datex Ohmeda Aespire View Aestiva/5 with 7900 Ventilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2013-08-05
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2013-08-05
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2002-04-12
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	1977-12-15
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2013-02-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2017-08-17
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2010-06-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	1977-12-15
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2021-05-27
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	1977-12-15
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2013-08-14
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2011-07-29
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2014-02-25
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-06-12
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2018-01-05
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2010-06-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-06-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-06-24
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	1977-12-15
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2011-01-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2010-06-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-06-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2011-09-22
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2010-06-24
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2011-01-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2015-04-28
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2010-06-24
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2012-01-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2022-01-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2017-11-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0008-2014	Draeger Medical, Inc.	2	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Z-0009-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2014	GE Healthcare, LLC	2	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Z-0010-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2112667. Last updated year: 2026. Please use registration number 2112667 when referencing this establishment in official correspondence.