FDA 510(k) Application Details - K102412

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K102412
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	EYEQUICK.LLC 1400 COMMON DRIVE EL PASO,TX, TX 79936 US Other 510(k) Applications for this Company
Contact	MARC ELLMAN MD 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	08/24/2010
Decision Date	06/23/2011
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	N
Expedited Review