INFANT VENTILATOR, (RESPIRATOR) PLAN B
Device Facts
| Record ID | K802583 |
|---|---|
| Device Name | INFANT VENTILATOR, (RESPIRATOR) PLAN B |
| Applicant | Healthdyne, Inc. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Dec 18, 1980 |
| 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.
