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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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