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K Number
K161727Device Name
Eyenez Ophthalmic Camera
Manufacturer
Date Cleared
2016-10-04
(104 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
EYENEZ LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Eyenez V200 fundus camera is intended to be used to capture images of the retina of the eye.
Device Description
The Eyenez Ophthalmic Camera is a handheld ophthalmic camera that combines a condensing lens with a built-in digital camera to capture a digital photograph of the retina and allow for the examination of the picture by an ophthalmic specialist. The Eyenez Ophthalmic Camera will allow users to capture images of the retina. Images may be saved to a flash memory card and also have connectivity towards PC using a USB interface. Device has a rechargeable battery.
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