Device Classification Name |
alternate controller enabled insulin infusion pump
|
510(k) Number |
K223213 |
Device Name |
Tandem Mobi Insulin Pump with Interoperable Technology |
Applicant |
Tandem Diabetes Care, Inc. |
11075 Roselle Street |
San Diego,
CA
92121
|
|
Applicant Contact |
Ashley Schneider |
Correspondent |
Tandem Diabetes Care, Inc. |
12400 High Bluff Drive |
San Diego,
CA
92130
|
|
Correspondent Contact |
Louise Focht |
Regulation Number | 880.5730
|
Classification Product Code |
|
Date Received | 10/17/2022 |
Decision Date | 07/10/2023 |
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
|
|
|