ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
Device Facts
| Record ID | K002686 |
|---|---|
| Device Name | ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E |
| Applicant | Nellcor Puritan Bennett, Inc. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Oct 18, 2000 |
| Decision | ST |
| 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.
