# K223670: MESI mTablet ECG Diagnostic System, MESI mTablet ECG

- Pathway: 510(k) (Traditional)
- Applicant: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
- Decided: Jul 28, 2023 after 233 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002074 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150289: Cardioline HD+, Cardioline S.P.A (2015) Summary page 5.

## Indications for use
The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function. MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations. The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information.

Source page: https://510kreport.com/device/K223670
Methodology: https://510kreport.com/methodology