K151236 is an FDA 510(k) clearance for the MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal). This device is classified as a Continuous Glucose Monitor Secondary Display (Class II - Special Controls, product code PJT).
Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on May 19, 2015, 8 days after receiving the submission on May 11, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1350. The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of A Continuous Glucose Monitoring System And Does Not Replace Primary Real Time Continuous Glucose Monitoring Or Standard Home Blood Glucose Monitoring.
| 510(k) Number | K151236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2015 |
| Decision Date | May 19, 2015 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PJT — Continuous Glucose Monitor Secondary Display |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1350 |
| Definition | The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of A Continuous Glucose Monitoring System And Does Not Replace Primary Real Time Continuous Glucose Monitoring Or Standard Home Blood Glucose Monitoring |