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 |