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FDA 510(k), K240058, AEYE-DS
FDA 510(k), K240058, AEYE-DS
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510(K) Number: K240058
Device Name: AEYE-DS
Manufacturer: Zack Dvey-Aharon
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: PIB
Classification Product Code: 01/08/2024
Date Received: 04/23/2024
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: AEYE-DS
Manufacturer: Zack Dvey-Aharon
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: PIB
Classification Product Code: 01/08/2024
Date Received: 04/23/2024
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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