FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VitreOx Anti-fog Solution
K Number: K163257
·
Decision May 24, 2017
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
26
Applicant Total
1
Review Days
191
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Basic Information
- Device Name
- VitreOx Anti-fog Solution
- K Number
- K163257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sio2 Nanotech, LLC
- Date Received
- November 14, 2016
- Decision Date
- May 24, 2017
- Product Code
- OCT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCT | Anti Fog Solution And Accessories, Endoscopy | FDA class 2 | Gastroenterology, Urology |
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