Clearance Summary
Automated ankle brachial pressure index measuring device, MESI mTABLET system received FDA 510(k) clearance under submission number K201046, sponsored by Mesi D.O.O.; Mesi, Development of Medical Devices, 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 2020-12-11.
- Submission: K201046
- Applicant / Sponsor: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 2020-12-11
Classification & Regulation
This clearance is catalogued under FDA product code JOM and 21 CFR 870.2780, within the Cardiovascular review panel as a Class II device.