FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OptiScanner 5000 Glucose Monitoring System
K Number: K162042
·
Decision Oct 16, 2017
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
1
Review Days
448
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Basic Information
- Device Name
- OptiScanner 5000 Glucose Monitoring System
- K Number
- K162042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optiscan Biomedical Corp.
- Date Received
- July 25, 2016
- Decision Date
- October 16, 2017
- Product Code
- LZF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LZF | Pump, Infusion, Analytical Sampling | FDA class 2 | General Hospital |
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