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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diabetic Retinopathy Detection Device
510(k) Number K200667
Device Name EyeArt
Applicant
Eyenuk, Inc
5850 Canoga Ave. Suite 250
Los Angeles,  CA  91367
Applicant Contact Kaushal Solanki
Correspondent
Eyenuk, Inc
5850 Canoga Ave. Suite 250
Los Angeles,  CA  91367
Correspondent Contact Kaushal Solanki
Regulation Number886.1100
Classification Product Code
PIB  
Date Received03/13/2020
Decision Date 08/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03112005
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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