Device Classification Name |
integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
|
510(k) Number |
K202145 |
Device Name |
Bigfoot Unity Diabetes Management System |
Applicant |
Bigfoot Biomedical, Inc. |
1820 McCarthy Blvd |
Milpitas,
CA
95035
|
|
Applicant Contact |
Kate Lee |
Correspondent |
Bigfoot Biomedical, Inc. |
1820 McCarthy Blvd |
Milpitas,
CA
95035
|
|
Correspondent Contact |
Kate Lee |
Regulation Number | 862.1355
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/31/2020 |
Decision Date | 05/07/2021 |
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
|
|
|