ESPIRT
Device Facts
| Record ID | K001208 |
|---|---|
| Device Name | ESPIRT |
| Applicant | Respironics, Inc. |
| Product Code | CBK · Anesthesiology |
| Decision Date | May 12, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
