FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
YUWELL Finger Pulse Oximeter
K Number: K212385
·
Decision Aug 16, 2022
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
3
Review Days
379
Basic Information
- Device Name
- YUWELL Finger Pulse Oximeter
- K Number
- K212385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Date Received
- August 2, 2021
- Decision Date
- August 16, 2022
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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