510(k) K222280
- Device
- Bigfoot Unity® Diabetes Management System
- Applicant
- Bigfoot Biomedical, Inc.
- 510(k) number
- K222280
- Product code
- QLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-01
- Date received
- 2022-07-29
- Regulation
- 862.1355
- Classification name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kate Lee
- Address
- 1820 Mccarthy Blvd. Milpitas CA US 95035 95035
FDA Registration Numbers#
- 3006371704
- 3003600763
- 3002807314
- 9710492
- 3004139819
- 3016525500
- 3008606429
- 3009171251
- 3010893867
- 3006537560
- 1450743
- 3007421145
- 3033394445
- 3011536730
- 2954323
Source Documents#
Other 510(k) Records For Product Code QLG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Abbott Diabetes Care, Inc. | 2023-02-21 |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022-05-26 |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022-05-26 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021-11-22 |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2021-08-11 |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021-07-30 |
| K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | 2021-05-07 |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020-06-12 |