Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-