ONZ · Mechanical Ventilator
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | ONZ |
|---|---|
| Device Name | Mechanical Ventilator |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152664 | TAV System | New Aera, Inc. | Dec 2, 2016 | SESE |
| K131562 | BREATHE NIOV VENTILATION SYSTEM | Breathe Technologies | Mar 6, 2014 | SESE |
| K103345 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | Feb 11, 2011 | SESE |
| K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | Dec 2, 2010 | SESE |
| K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | Breathe Technologies, Inc. | Apr 23, 2010 | SESE |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Breathe Technologies, Inc. | Jul 20, 2009 | SESE |
Top Applicants
- Breathe Technologies, Inc. — 4 clearances
- Breathe Technologies — 1 clearance
- New Aera, Inc. — 1 clearance
