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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 K122384
Device Name MINISPIR
Applicant
MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA,  IT 00155
Applicant Contact GERDA VAN HOUTS
Correspondent
MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA,  IT 00155
Correspondent Contact GERDA VAN HOUTS
Regulation Number868.1840
Classification Product Code
BZG  
Subsequent Product Code
DQA  
Date Received08/06/2012
Decision Date 10/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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