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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 K120577
Device Name MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
Applicant
MEDIKRO OY
KELLOLAHDENTIE 27
KUOPIO,  FI FI-70460
Applicant Contact MIKKO ELORANTA
Correspondent
MEDIKRO OY
KELLOLAHDENTIE 27
KUOPIO,  FI FI-70460
Correspondent Contact MIKKO ELORANTA
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/27/2012
Decision Date 06/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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