Device Classification Name |
interoperable automated glycemic controller, insulin suspend
|
510(k) Number |
K193483 |
Device Name |
Basal-IQ Technology |
Applicant |
Tandem Diabetes Care, Inc. |
11075 Roselle Street |
San Diego,
CA
92121
|
|
Applicant Contact |
Trevor J Dendo |
Correspondent |
Tandem Diabetes Care, Inc. |
11075 Roselle Street |
San Diego,
CA
92121
|
|
Correspondent Contact |
Trevor J Denbo |
Regulation Number | 862.1356
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/17/2019 |
Decision Date | 02/28/2020 |
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
|
|
|