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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 K043528
Device Name SPIROTEL
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  
Subsequent Product Code
DQA  
Date Received12/21/2004
Decision Date 07/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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