FDA 510(k) Application Details - K111988

Device Classification Name	Ophthalmoscope,Laser,Scanning   More FDA Info for this Device
510(K) Number	K111988
Device Name	Ophthalmoscope,Laser,Scanning
Applicant	I-OPTICS BV 220 RIVER ROAD CLAREMONT, NH 03743 US Other 510(k) Applications for this Company
Contact	WILLIAM GREENROSE Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	MYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2011
Decision Date	10/28/2011
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