Centervue Macular Integrity Assessment
FDA 510(k) K133758 · Centervue S.P.A.
510(k) numberK133758
Submission
- Device name
- Centervue Macular Integrity Assessment
- Applicant
- Centervue S.P.A.
Rome, IT - Received
- December 11, 2013
- Decision date
- April 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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Questions and answers
When was Centervue Macular Integrity Assessment cleared by the FDA?
Centervue Macular Integrity Assessment (K133758) received a 510(k) decision of Substantially Equivalent on April 23, 2014, 133 days after the submission was received.
What is the product code of K133758?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.