MODEL 105 VENTILATOR, MODIFICATION
Device Facts
| Record ID | K922477 |
|---|---|
| Device Name | MODEL 105 VENTILATOR, MODIFICATION |
| Applicant | Infrasonics Corp. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Aug 24, 1992 |
| 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.
