1
/
of
0
FDA 510(k), K221183, AEYE-DS
FDA 510(k), K221183, AEYE-DS
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
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
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
Couldn't load pickup availability
- 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.
View full details