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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K201046
Device Name Automated ankle brachial pressure index measuring device, MESI mTABLET system
Applicant
Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Leskoskova Cesta 11a
Ljubljana,  SI 1000
Applicant Contact Jakob Susteric
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number870.2780
Classification Product Code
JOM  
Date Received04/21/2020
Decision Date 12/11/2020
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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