| Device | 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 Companyp.o. Box 7550madison, WI 53707-7550 PMA NumberP210018 Date Received05/03/2021 Decision Date03/17/2022 Product Code QSF Advisory Committee Anesthesiology Clinical TrialsNCT02972892 Expedited Review Granted? No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-03-17 |
| PMA | P210018 |
| Supplement | S |
| Product Code | QSF |
| Advisory Committee | Anesthesiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Datex-Ohmeda, Inc., A General Electric Company p.o. Box 7550 madison, WI 53707-7550 PMA NumberP210018 Date Received05/03/2021 Decision Date03/17/2022 Product Code QSF Advisory Committee Anesthesiology Clinical TrialsNCT02972892 Expedited Review Granted? No Combination ProductNo 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 Adult Patients, 18 Years Of Age And Older.The Aisys CS2 Anesthesia System And The Et Control Feature Are Intended For Prescription Use Only. Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210018 | Original Filing |
| Device ID | PMA | Supp |
|---|---|---|
| 00195278579157 | P210018 | 000 |