FDA 510(k) Application Details - K230627

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K230627
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Zilia Inc. 125 Charest Boulevard East Suite 400 Quebec City G1K3G5 CA Other 510(k) Applications for this Company
Contact	Sauvageau Patrick 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	03/06/2023
Decision Date	11/20/2023
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