FDA 510(k) Application Details - K110986

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K110986
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	OPTOMED OY HALLITUSKATU 13-17 D 96 OULU 90100 FI Other 510(k) Applications for this Company
Contact	LAURA PIILA 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	04/08/2011
Decision Date	05/16/2011
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	Y
Expedited Review