Clearance Summary
Reusable Temperature Probe, Disposable Temperature Probe received FDA 510(k) clearance under submission number K223807, sponsored by Shenzhen Sino-K Medical Technology Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-08-25.
- Submission: K223807
- Applicant / Sponsor: Shenzhen Sino-K Medical Technology Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2023-08-25
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.