FDA 510(k) Application Details - K142897

Device Classification Name	Ophthalmoscope,Laser,Scanning   More FDA Info for this Device
510(K) Number	K142897
Device Name	Ophthalmoscope,Laser,Scanning
Applicant	OPTOS PLC. QUEENSFERRY HOUSE, CARNEGIE BUSINESS CAMPUS DUNFERMLINE KY11 8GR GB Other 510(k) Applications for this Company
Contact	GUNHILD PAULSEN 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	10/03/2014
Decision Date	01/16/2015
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