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FDA 510(k), K200667, EyeArt
FDA 510(k), K200667, EyeArt
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510(K) Number: K200667
Device Name: EyeArt
Manufacturer: Eyenuk, Inc
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 03/13/2020
Decision Date: 08/03/2020
Regulation Medical Specialty: Ophthalmic
Device Name: EyeArt
Manufacturer: Eyenuk, Inc
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 03/13/2020
Decision Date: 08/03/2020
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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