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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K223670
Device Name MESI mTablet ECG Diagnostic System, MESI mTablet ECG
Applicant
Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Leskoskova Cesta 11 A
Ljubljana,  SI 1000
Applicant Contact Jakob Susteric
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/07/2022
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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