Clearance Summary
Tempus Pro Patient Monitor received FDA 510(k) clearance under submission number K173768, sponsored by Remote Diagnostic Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-01-10.
- Submission: K173768
- Applicant / Sponsor: Remote Diagnostic Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2018-01-10
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.