FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CORVIS ST
K Number: K113066
·
Decision Nov 8, 2012
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
56
Applicant Total
5
Review Days
388
Basic Information
- Device Name
- CORVIS ST
- K Number
- K113066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OCULUS OPTIKGERATE GMBH
- Date Received
- October 17, 2011
- Decision Date
- November 8, 2012
- Product Code
- HKX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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