Datex-Ohmeda Inc., A Division of Instrumentarium C
United StatesFDA applicant, unverified
- Devices
- 2
What Datex-Ohmeda Inc., A Division of Instrumentarium C makes
Datex-Ohmeda Inc. manufactures anesthesia workstations, including the Engström Carestation and Engström Pro series, as well as portable anesthesia machines like the Aespire 7900 and Aespire View. These devices are designed for monitoring and delivering gases, vapors, and oxygen during surgical procedures, with integrated ventilation and patient safety features.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Engstrom Carestation, Engstrom Pro Ref K093886
Regimes: 510(k) Registry: 510(k)Aespire 7900, Aespire View Ref K092864
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Datex-Ohmeda Inc., A Division of Instrumentarium C have in the registry?
The registry currently lists 2 devices for Datex-Ohmeda Inc., A Division of Instrumentarium C. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datex-Ohmeda Inc., A Division of Instrumentarium C's devices?
Among its 2 most recently registered devices, Datex-Ohmeda Inc., A Division of Instrumentarium C has devices listed in FDA 510(k) (2 devices).
What risk classes do Datex-Ohmeda Inc., A Division of Instrumentarium C's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Datex-Ohmeda Inc., A Division of Instrumentarium C's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Datex-Ohmeda Inc., A Division of Instrumentarium C in the registry?
The most recently registered devices listed for Datex-Ohmeda Inc., A Division of Instrumentarium C include ENGSTROM CARESTATION, ENGSTROM PRO and AESPIRE 7900, AESPIRE VIEW.