FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Signos Glucose Monitoring System
K Number: K250106
·
Decision Mar 21, 2025
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
1
Review Days
65
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Basic Information
- Device Name
- Signos Glucose Monitoring System
- K Number
- K250106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signos, Inc.
- Date Received
- January 15, 2025
- Decision Date
- March 21, 2025
- Product Code
- SAF
- 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 |
|---|---|---|---|
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | FDA class 2 | Clinical Chemistry |
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