Clearance Summary
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) received FDA 510(k) clearance under submission number K151236, sponsored by Medtronic Minimed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2015-05-19.
- Submission: K151236
- Applicant / Sponsor: Medtronic Minimed, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1350
- Decision date: 2015-05-19
Classification & Regulation
This clearance is catalogued under FDA product code PJT and 21 CFR 862.1350, within the Clinical Chemistry review panel as a Class II device.