FDA 510(k) Application Details - K200254

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K200254
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Optina Diagnostics 7405 Route Transcanadienne, Suite 300 Montreal H4T 1Z2 CA Other 510(k) Applications for this Company
Contact	Jean-Philippe Sylvestre 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	02/03/2020
Decision Date	04/27/2020
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