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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K251777
Device Name MESI mTABLET SPIRO
Applicant
Mesi D.O.O.
Leskoskova Cesta 11 A
Ljubljana,  SI 1000
Applicant Contact Nejc Ludvik
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number868.1840
Classification Product Code
BZG  
Date Received06/10/2025
Decision Date 03/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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