Device Classification Name |
Pump, Infusion, Insulin
|
510(k) Number |
K211575 |
Device Name |
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System |
Applicant |
Insulet Corporation |
100 Nagog Park |
Acton,
MA
01720
|
|
Applicant Contact |
Dennis Shay |
Correspondent |
Insulet Corporation |
100 Nagog Park |
Acton,
MA
01720
|
|
Correspondent Contact |
Dennis Shay |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/21/2021 |
Decision Date | 08/13/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|