K242775 is an FDA 510(k) clearance for the InPen System App (MMT-8060 (iOS), MMT-8061 (Android)). This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on November 12, 2024, 60 days after receiving the submission on September 13, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K242775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2024 |
| Decision Date | November 12, 2024 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDC — Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |