FDA 510(k) Application Details - K113066

Device Classification Name	Tonometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K113066
Device Name	Tonometer, Ac-Powered
Applicant	OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 WETZLAR D-35582 DE Other 510(k) Applications for this Company
Contact	ECKHARD LOH Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2011
Decision Date	11/08/2012
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