OMICRON MONITOR, DELTA MONITOR
Device Facts
| Record ID | K960861 |
|---|---|
| Device Name | OMICRON MONITOR, DELTA MONITOR |
| Applicant | Core-M, Inc. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Aug 19, 1996 |
| Decision | ST |
| 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.
