The following data is part of a premarket notification filed by Medtronic Minimed, Inc. with the FDA for Minimed Connect Kit, Minimed Connect Uploader, Minimed Connect App, Carelink Connect (carelink Personal).
| Device ID | K151236 |
| 510k Number | K151236 |
| Device Name: | MiniMed Connect Kit, MiniMed Connect Uploader, MiniMed Connect App, CareLink Connect (CareLink Personal) |
| Classification | Continuous Glucose Monitor Secondary Display |
| Applicant | MEDTRONIC MINIMED, INC. 18000 Devonshire Street Northridge, CA 91325 |
| Contact | Liane R. Miller |
| Correspondent | Liane R. Miller MEDTRONIC MINIMED, INC. 18000 Devonshire Street Northridge, CA 91325 |
| Product Code | PJT |
| CFR Regulation Number | 862.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-11 |
| Decision Date | 2015-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169873827 | K151236 | 000 |
| 00643169631373 | K151236 | 000 |