Clearance Summary
Tempus Pro Patient Monitor received FDA 510(k) clearance under submission number K170567, sponsored by Remote Diagnostic Technologies , 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 2017-07-06.
- Submission: K170567
- Applicant / Sponsor: Remote Diagnostic Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2017-07-06
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.