Clearance Summary
Reusable and Disposable SpO2 Sensors received FDA 510(k) clearance under submission number K201360, sponsored by Xinkang Medical Instrument 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 2020-08-19.
- Submission: K201360
- Applicant / Sponsor: Xinkang Medical Instrument Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2020-08-19
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.