FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K Number: K020866
·
Decision Jun 11, 2002
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
37
Review Days
85
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Basic Information
- Device Name
- FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
- K Number
- K020866
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Diabetes Care, Inc.
- Date Received
- March 18, 2002
- Decision Date
- June 11, 2002
- Product Code
- NBW
- 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Nov 22, 2021 | Substantially Equivalent |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Aug 11, 2021 | Substantially Equivalent |
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