Clearance Summary
TEMPUS PRO WITH ENHANCED FEATURES received FDA 510(k) clearance under submission number K133973, sponsored by Remote Diagnostic Technologies , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-08-14.
- Submission: K133973
- Applicant / Sponsor: Remote Diagnostic Technologies , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2014-08-14
Classification & Regulation
This clearance is catalogued under FDA product code QYW and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.