Portable Oxygen Concentrator (PO1 5B, PO1 6B)
Device Facts
| Record ID | K260171 |
|---|---|
| Device Name | Portable Oxygen Concentrator (PO1 5B, PO1 6B) |
| Applicant | BMC Medical Co., Ltd. |
| Product Code | CAW · Anesthesiology |
| Decision Date | Aug 14, 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).
