510(k) K242775
K242775 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "InPen System App (MMT-8060 (iOS), MMT-8061 (Android))". The FDA issued a decision of Substantially Equivalent on November 12, 2024. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Medtronic Minimed has at least 10 other 510(k) clearances on record.
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