Diabetic Retinopathy Detection Device

AEYE Health, Inc.

The following data is part of a premarket notification filed by Aeye Health, Inc. with the FDA for Aeye-ds.

Pre-market Notification Details

Device IDK221183
510k NumberK221183
Device Name:AEYE-DS
ClassificationDiabetic Retinopathy Detection Device
Applicant AEYE Health, Inc. 200 Park Avenue (17th Floor) New York,  NY  10166
ContactZack Dvey-Aharon
CorrespondentJohn Smith
Hogan Lovells US LLP 555 13th Street NW Washington,  DC  20004
Product CodePIB  
CFR Regulation Number886.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-11-10

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