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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 K052140
Device Name SPIROLAB, SPIROLAB II
Applicant
MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA,  IT 00155
Applicant Contact SIMON FOWLER
Correspondent
MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA,  IT 00155
Correspondent Contact SIMON FOWLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/08/2005
Decision Date 03/16/2006
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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