The following data is part of a premarket notification filed by Aeye Health, Inc. with the FDA for Aeye-ds.
Device ID | K221183 |
510k Number | K221183 |
Device Name: | AEYE-DS |
Classification | Diabetic Retinopathy Detection Device |
Applicant | AEYE Health, Inc. 200 Park Avenue (17th Floor) New York, NY 10166 |
Contact | Zack Dvey-Aharon |
Correspondent | John Smith Hogan Lovells US LLP 555 13th Street NW Washington, DC 20004 |
Product Code | PIB |
CFR Regulation Number | 886.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-04-25 |
Decision Date | 2022-11-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850035651018 | K221183 | 000 |
00850035651001 | K221183 | 000 |
00085003651022 | K221183 | 000 |
00085003651039 | K221183 | 000 |