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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 K221183
Device Name AEYE-DS
Applicant
AEYE Health, Inc.
200 Park Avenue (17th Floor)
New York,  NY  10166
Applicant Contact Zack Dvey-Aharon
Correspondent
Hogan Lovells US LLP
555 13th Street NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number886.1100
Classification Product Code
PIB  
Date Received04/25/2022
Decision Date 11/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT04612868
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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