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FDA 510(k), K213037, IDx-DR v2.3
FDA 510(k), K213037, IDx-DR v2.3
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$149.00 USD
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510(K) Number: K213037
Device Name: IDx-DR v2.3
Manufacturer: Digital Diagnostics Inc.
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 09/21/2021
Decision Date: 06/17/2022
Regulation Medical Specialty: Ophthalmic
Device Name: IDx-DR v2.3
Manufacturer: Digital Diagnostics Inc.
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 09/21/2021
Decision Date: 06/17/2022
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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