PMA
P210018: Et Control
FDA PMA · Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents · Datex-Ohmeda, Inc., A General Electric Company
Key facts
| 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 |
| Owner/operator | GE HealthCare Technologies Inc. |
| Product code | QSF |
| Approval date | Mar 17, 2022 |
| Docket number | 22M-0360 |
| Notice date | Mar 21, 2022 |
| Establishment registration | 2112667 |
| FEI number | 2112667 |
At a glance
- None Supplements
- Mar 17, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: