INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
Device Facts
| Record ID | K003472 |
|---|---|
| Device Name | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM |
| Applicant | Sequal Technologies, Inc. |
| Product Code | CAW · Anesthesiology |
| Decision Date | Jun 4, 2001 |
| 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).
