Clearance Summary
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI received FDA 510(k) clearance under submission number K213730, sponsored by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-04-21.
- Submission: K213730
- Applicant / Sponsor: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 2022-04-21
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.