Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
FDA 510(k) clearance K250625 · decided 2025-08-27
Clearance details
- K-number
- K250625
- Device name
- Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
- Applicant
- Nanjing Yinuoji Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-03
- Decision date
- 2025-08-27
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Nanjing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.