MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
Device Facts
| Record ID | K962517 |
|---|---|
| Device Name | MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV |
| Applicant | Healthdyne Technologies, Inc. |
| Product Code | MNS · Anesthesiology |
| Decision Date | Feb 20, 1997 |
| 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.
