FDA 510(k) Application Details - K081858

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K081858
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 PLEASANTON, CA 94588-4084 US Other 510(k) Applications for this Company
Contact	GARY A SEEGER 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	07/01/2008
Decision Date	11/05/2008
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