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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 K240058
Device Name AEYE-DS
Applicant
Aeye Health, Inc.
200 Park Ave. (17th Floor)
New York,  NY  10166
Applicant Contact Zack Dvey-Aharon
Correspondent
A. Stein-Regulatory Affairs Consulting, Ltd.
18 Hata'As St.
Kfar Saba,  IL 4442518
Correspondent Contact Ahava Stein
Regulation Number886.1100
Classification Product Code
PIB  
Date Received01/08/2024
Decision Date 04/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05857943
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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