PRIME AIRE O2 PLUS 2
Device Facts
| Record ID | K851437 |
|---|---|
| Device Name | PRIME AIRE O2 PLUS 2 |
| Applicant | Invacare Corp. |
| Product Code | CAW · Anesthesiology |
| Decision Date | Jul 29, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5440 |
| Device Class | Class 2 |
Regulatory Classification
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).
