K223670 is an FDA 510(k) clearance for the MESI mTablet ECG Diagnostic System, MESI mTablet ECG. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on July 28, 2023, 233 days after receiving the submission on December 7, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K223670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2022 |
| Decision Date | July 28, 2023 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |