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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K081033
Device Name MIROXI
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 Number870.2700
Classification Product Code
DQA  
Date Received04/11/2008
Decision Date 01/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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