FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bigfoot Unity Diabetes Management System
K Number: K202145
·
Decision May 7, 2021
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
8
Applicant Total
2
Review Days
280
Basic Information
- Device Name
- Bigfoot Unity Diabetes Management System
- K Number
- K202145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bigfoot Biomedical, Inc.
- Date Received
- July 31, 2020
- Decision Date
- May 7, 2021
- Product Code
- QLG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | FDA class 2 | Clinical Chemistry |
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Other Clearances by Bigfoot Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222280 | Bigfoot Unity® Diabetes Management System | Mar 1, 2023 | Substantially Equivalent |