Clearance Summary
TEMPUS PRO EXTENDED FEATURES received FDA 510(k) clearance under submission number K133988, 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 2014-05-16.
- Submission: K133988
- Applicant / Sponsor: Remote Diagnostic Technologies , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2014-05-16
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.