MESI mTablet ECG Diagnostic System, MESI mTablet ECG— 510(k) K223670
Substantially EquivalentMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
FDA 510(k) clearance K223670 for MESI mTablet ECG Diagnostic System, MESI mTablet ECG, Substantially Equivalent on 2023-07-28. Applicant: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O..
Clearance details
- Applicant
- Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ljubljana, SI
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.