K201046 is an FDA 510(k) clearance for the Automated ankle brachial pressure index measuring device, MESI mTABLET system. This device is classified as a Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II - Special Controls, product code JOM).
Submitted by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. (Ljubljana, SI). The FDA issued a Cleared decision on December 11, 2020, 234 days after receiving the submission on April 21, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2780.
| 510(k) Number | K201046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2020 |
| Decision Date | December 11, 2020 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2780 |