Device Classification Name |
continuous glucose monitor secondary display
|
510(k) Number |
K151236 |
Device Name |
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) |
Applicant |
MEDTRONIC MINIMED, INC. |
18000 Devonshire Street |
Northridge,
CA
91325
|
|
Applicant Contact |
Liane R. Miller |
Correspondent |
MEDTRONIC MINIMED, INC. |
18000 Devonshire Street |
Northridge,
CA
91325
|
|
Correspondent Contact |
Liane R. Miller |
Regulation Number | 862.1350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/11/2015 |
Decision Date | 05/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|