Oxygen Concentrator (OX-5A, OX-5C)
FDA 510(k) clearance K252965 · decided 2026-05-29
Clearance details
- K-number
- K252965
- Device name
- Oxygen Concentrator (OX-5A, OX-5C)
- Applicant
- Oxytek Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-17
- Decision date
- 2026-05-29
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chencun Town, Shunde District, Foshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.