AMS 3000 PORTABLE JET VENTILATOR
Device Facts
| Record ID | K900744 |
|---|---|
| Device Name | AMS 3000 PORTABLE JET VENTILATOR |
| Applicant | Acutronic Medical Systems AG |
| Product Code | CBK · Anesthesiology |
| Decision Date | Apr 29, 1991 |
| 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.
