FDA 510(k) Application Details - K203629

Device Classification Name	More FDA Info for this Device
510(K) Number	K203629
Device Name	IDx-DR
Applicant	Digital Diagnostics Inc. 2300 Oakdale Blvd. Coralville, IA 52241 US Other 510(k) Applications for this Company
Contact	Ashley Miller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2020
Decision Date	06/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review