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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 K983909
Device Name MIR SPIROBANK SPIROMETER
Applicant
Mir Medical Intl. Research Srl
Vicolo Maddalena 22/A
Albano Laziale, Roma,  IT 00041
Applicant Contact SIMON FOWLER
Correspondent
Mir Medical Intl. Research Srl
Vicolo Maddalena 22/A
Albano Laziale, Roma,  IT 00041
Correspondent Contact SIMON FOWLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/03/1998
Decision Date 12/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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