Clearance Summary
Disposable SpO2 Sensor received FDA 510(k) clearance under submission number K192608, sponsored by Shenzhen Sino-K Medical Technology 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 2020-01-24.
- Submission: K192608
- Applicant / Sponsor: Shenzhen Sino-K Medical Technology Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2020-01-24
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.