Oxygen Concentrator (OX-5A, OX-5C)
Device Facts
| Record ID | K252965 |
|---|---|
| Device Name | Oxygen Concentrator (OX-5A, OX-5C) |
| Applicant | Oxytek Medical Technology Co., Ltd. |
| Product Code | CAW · Anesthesiology |
| Decision Date | May 29, 2026 |
| 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).
