Clearance Summary
YUWELL Finger Pulse Oximeter received FDA 510(k) clearance under submission number K212385, sponsored by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-08-16.
- Submission: K212385
- Applicant / Sponsor: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2022-08-16
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.