NOU · Continuous, Ventilator, Home Use
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | NOU |
|---|---|
| Device Name | Continuous, Ventilator, 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233452 | Vivo 45 LS | Breas Medical AB | Jan 13, 2025 | SESE |
| K193586 | Vivo 45 LS | Breas Medical AB | Jan 27, 2021 | SESE |
| K160481 | Vivo 60 | Breas Medical AB | Nov 9, 2016 | SESE |
| K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | Jun 18, 2013 | SESE |
| K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 | Respironics California, Inc. | Mar 16, 2004 | SESE |
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 | Respironics California, Inc. | Nov 20, 2003 | SESE |
| K021981 | IVENT 201 PORTABLE VENTILATOR | Versamed , Ltd. | Aug 13, 2003 | SESE |
Top Applicants
- Breas Medical AB — 3 clearances
- Respironics California, Inc. — 2 clearances
- Ge Healthcare, Breas Medical AB — 1 clearance
- Versamed , Ltd. — 1 clearance
