NQY · Ventilator, Continuous, Minimal Ventilatory Support, Home Use
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | NQY |
|---|---|
| Device Name | Ventilator, Continuous, Minimal Ventilatory Support, Home Use |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
