PMA P210018
- Device
- Et Control
- Applicant
- Datex-Ohmeda, Inc., A General Electric Company
- PMA number
- P210018
- Product code
- QSF
- Decision date
- 2022-03-17
- Generic name
- Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents
- Approval order statement
- Approval for Et Control indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The Et Control feature is indicated for patients, 18 years of age and older.The Aisys CS2 anesthesia system and the Et Control feature are intended for prescription use only.
Current openFDA PMA Record#
- Device
- Et Control
- Applicant
- Datex-Ohmeda, Inc., A General Electric Company
- PMA number
- P210018
- Product code
- QSF
- Generic name
- Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents
- Decision date
- 2022-03-17
- Decision code
- APPR
- Date received
- 2021-05-03
- Approval order statement
- Approval for Et Control indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The Et Control feature is indicated for patients, 18 years of age and older.The Aisys CS2 anesthesia system and the Et Control feature are intended for prescription use only.