FDA 510(k) Application Details - K231230

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K231230
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Optina Diagnostics Inc. 8200 Decarie Boulevard Montreal H4P 2P5 CA Other 510(k) Applications for this Company
Contact	Sarah Lemaire Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2023
Decision Date	12/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review