Et Control
FDA premarket approval P210018 · decided 2022-03-17
Approval details
- PMA number
- P210018
- Trade name
- Et Control
- Generic name
- Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents
- Applicant
- Datex-Ohmeda, Inc., A General Electric Company
- Date received
- 2021-05-03
- Decision date
- 2022-03-17
- Days to decision
- 318 days
- Decision code
- APPR
- Product code
- QSF
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Madison, WI
- 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 pr
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