FDA 510(k) Application Details - K132186

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K132186
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	OPTOMED OY Hallituskatu 13-17 D Oulu 90100 FI Other 510(k) Applications for this Company
Contact	JYRI LESKELA, QUALITY MANAGER 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	07/15/2013
Decision Date	12/18/2013
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