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FDA 510(k), K203629, IDx-DR
FDA 510(k), K203629, IDx-DR
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510(K) Number: K203629
Device Name: IDx-DR
Manufacturer: Digital Diagnostics Inc.
Device Classification Name: diabetic retinopathy detection device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 12/11/2020
Decision Date: 06/10/2021
Regulation Medical Specialty: Ophthalmic
Device Name: IDx-DR
Manufacturer: Digital Diagnostics Inc.
Device Classification Name: diabetic retinopathy detection device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 12/11/2020
Decision Date: 06/10/2021
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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