Device Classification Name |
alternate controller enabled insulin infusion pump
|
510(k) Number |
K233044 |
Device Name |
Tandem Mobi insulin pump with interoperable technology |
Applicant |
Tandem Diabetes Care Inc. |
12400 High Bluff Drive |
San Diego,
CA
92130
|
|
Applicant Contact |
Louise Focht |
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 | 09/25/2023 |
Decision Date | 10/05/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|