FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K Number: K133758
·
Decision Apr 23, 2014
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
86
Applicant Total
13
Review Days
133
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Basic Information
- Device Name
- CENTERVUE MACULAR INTEGRITY ASSESSMENT
- K Number
- K133758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centervue S.P.A.
- Date Received
- December 11, 2013
- Decision Date
- April 23, 2014
- Product Code
- HLI
- 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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | FDA class 2 | Ophthalmic |
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