Clearance Summary
Tempus LS - Manual received FDA 510(k) clearance under submission number K200849, sponsored by Remote Diagnostic Technologies, Ltd. A Philips Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-07-24.
- Submission: K200849
- Applicant / Sponsor: Remote Diagnostic Technologies, Ltd. A Philips Company
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2020-07-24
Classification & Regulation
This clearance is catalogued under FDA product code LDD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.