FDA 510(k), K221183, AEYE-DS

510(K) Number: K221183
Device Name: AEYE-DS
Manufacturer: AEYE Health, Inc.
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 04/25/2022
Decision Date: 11/10/2022
Regulation Medical Specialty: Ophthalmic

Total Pages: 2,549
Fully Redacted Pages: 2,181
Content Pages: 368