FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
K Number: K250625
·
Decision Aug 27, 2025
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
1
Review Days
177
Basic Information
- Device Name
- Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
- K Number
- K250625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanjing Yinuoji Medical Technology Co., Ltd.
- Date Received
- March 3, 2025
- Decision Date
- August 27, 2025
- Product Code
- CAW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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