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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K253512
Device Name MiniMed Go App
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge
Los Angeles,  CA  92883
Applicant Contact Ajay Aluru
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge
Los Angeles,  CA  92883
Correspondent Contact Ajay Aluru
Regulation Number868.1890
Classification Product Code
NDC  
Date Received11/06/2025
Decision Date 01/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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