OMNI-VENT, SERIES D/MRI
Device Facts
| Record ID | K881420 |
|---|---|
| Device Name | OMNI-VENT, SERIES D/MRI |
| Applicant | Stein-Gates Medical Equipment, Inc. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Jun 14, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
