510(k) K151236
- Device
- MiniMed Connect Kit, MiniMed Connect Uploader, MiniMed Connect App, CareLink Connect (CareLink Personal)
- Applicant
- MEDTRONIC MINIMED, INC.
- 510(k) number
- K151236
- Product code
- PJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-19
- Date received
- 2015-05-11
- Regulation
- 862.1350
- Classification name
- Continuous Glucose Monitor Secondary Display
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Liane R. Miller
- Address
- 18000 Devonshire St. Northridge CA US 91325 91325
FDA Registration Numbers#
- 3008770957
- 3004753838
- 2134850
- 2032227
- 3028013069
- 3007981285
- 3014700242
- 3017181032
- 3031700059
- 2954323
- 3009862700
Source Documents#
Other 510(k) Records For Product Code PJT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN140038 | Dexcom Share Direct Secondary Displays | Dexcom, Inc. | 2015-01-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary