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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 K230501
Device Name Spirobank Oxi
Applicant
Mir Medical International Research USA
5462 S. Westridge Dr.
New Berlin,  WI  53151
Applicant Contact Dale Novy
Correspondent
Mir Medical International Research USA
Viale Luigi Schiavonetti 270 – Cap 00173
Rome,  IT
Correspondent Contact Alessio Segreto
Regulation Number868.1840
Classification Product Code
BZG  
Subsequent Product Code
DQA  
Date Received02/24/2023
Decision Date 12/15/2023
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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