FDA 510(k) Application Details - K082196

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K082196
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	IMEDOS GMBH 317 SHORE BREEZE LANE LEAGUE CITY, TX 77573 US Other 510(k) Applications for this Company
Contact	HANS STROMEYER 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	08/04/2008
Decision Date	06/16/2009
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