FDA 510(k) Application Details - K201325

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K201325
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Optomed Oyj Yrttipellontie 1 Oulu 90230 FI Other 510(k) Applications for this Company
Contact	Jyri LeskelΣ 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	05/18/2020
Decision Date	11/20/2020
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