510(k) K250625
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) by
Nanjing Yinuoji Medical Technology Co., Ltd.
— Product Code CAW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2025
- Date Received
- March 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type