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510(k) K242775

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) by Medtronic Minimed — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2024
Date Received
September 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

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