Oxygen Concentrator, Model JAY-5AW
FDA 510(k) clearance K213210 · decided 2022-12-08
Clearance details
- K-number
- K213210
- Device name
- Oxygen Concentrator, Model JAY-5AW
- Applicant
- Longfian Scitech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-29
- Decision date
- 2022-12-08
- Days to decision
- 435 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Baoding, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| React Health PHOENIX 5L Oxygen Concentrator recall (Z-1815-2026) | 3B Medical, Inc. | 2026-04-15 |