Device Classification Name |
Pump, Infusion, Insulin
|
510(k) Number |
K162296 |
Device Name |
OmniPod Insulin Management System |
Applicant |
INSULET CORPORATION |
600 TECHNOLOGY PARK DRIVE |
SUITE 200 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
MATTHEW KING |
Correspondent |
INSULET CORPORATION |
600 TECHNOLOGY PARK DRIVE |
SUITE 200 |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
MATTHEW KING |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/16/2016 |
Decision Date | 04/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|