510(k) K212385
K212385 is an FDA 510(k) premarket notification submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. for the device "YUWELL Finger Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on August 16, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2022
- Date Received
- August 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type