OLF · Medevac Use Oxygen Generator
Anesthesiology · 21 CFR 868.5440 · Class 2
Overview
| Product Code | OLF |
|---|---|
| Device Name | Medevac Use Oxygen Generator |
| Regulation | 21 CFR 868.5440 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082829 | AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) | Carleton Life Support Systems, Inc. | Dec 22, 2008 | SESE |
Top Applicants
- Carleton Life Support Systems, Inc. — 1 clearance
