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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 K213730
Device Name MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
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 Number870.2780
Classification Product Code
JOM  
Date Received11/26/2021
Decision Date 04/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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