Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

K-Number: K242775 · 2024-11-12

ApplicantMedtronic Minimed
Decision Date2024-11-12
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is a medical device manufactured by Medtronic Minimed. It received FDA 510(k) clearance on 2024-11-12 under approval number K242775. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is a medical device that received FDA 510(k) clearance on 2024-11-12. It is manufactured by Medtronic Minimed. The 510(k) number is K242775.

When was InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) approved by the FDA?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) received FDA 510(k) clearance on 2024-11-12, under approval number K242775.

What company makes InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is manufactured by Medtronic Minimed.

What is the FDA product code for InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

The FDA product code for InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is NDC.

Related Clinical Trials

NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07573098 Digital Tool for Improved Self-management of COPD RECRUITING NCT06271577 Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II RECRUITING

Other Devices by Medtronic Minimed

K160860MiniMed Quick-serter K241622Extended Reservoir; MiniMed Reservoir K253701SmartGuard Technology; Predictive Low Glucose Technology K253512MiniMed Go App PMA P150019Sensor, glucose, invasive PMA P150001Automated insulin dosing , threshold suspend

View all 10 devices →

Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K161433Insulia Diabetes Management CompanionVoluntis Sa. K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑