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FDA 510(k)

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

K-Number: K223670 · 2023-07-28

ApplicantMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Decision Date2023-07-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MESI mTablet ECG Diagnostic System, MESI mTablet ECG is a medical device manufactured by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. It received FDA 510(k) clearance on 2023-07-28 under approval number K223670. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

MESI mTablet ECG Diagnostic System, MESI mTablet ECG is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. The 510(k) number is K223670.

When was MESI mTablet ECG Diagnostic System, MESI mTablet ECG approved by the FDA?

MESI mTablet ECG Diagnostic System, MESI mTablet ECG received FDA 510(k) clearance on 2023-07-28, under approval number K223670.

What company makes MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

MESI mTablet ECG Diagnostic System, MESI mTablet ECG is manufactured by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O..

What is the FDA product code for MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

The FDA product code for MESI mTablet ECG Diagnostic System, MESI mTablet ECG is DPS.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

Related Devices (Code: DPS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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