510(k) K203629— IDx-DR

Substantially Equivalent

Digital Diagnostics, Inc.

Clearance details

Applicant: Digital Diagnostics, Inc.
Product code: Code PIB
Advisory panel: Ophthalmic
Date received: 2020-12-11
Decision date: 2021-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

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