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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 K242775
Device Name InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  92325
Applicant Contact Ty Cowart
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  92325
Correspondent Contact Ty Cowart
Regulation Number868.1890
Classification Product Code
NDC  
Date Received09/13/2024
Decision Date 11/12/2024
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
Recalls CDRH Recalls
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