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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
AEYE Health, Inc.
200 Park Avenue (17th Floor)
New York,  NY  10166
Applicant Contact Zack Dvey-Aharon
Hogan Lovells US LLP
555 13th Street NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number886.1100
Classification Product Code
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