FDA 510(k) Application Details - K133758

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K133758
Device Name	Ophthalmoscope, Ac-Powered
Applicant	CENTERVUE SPA PIAZZA ALBANIA 10 ROME 00153 IT Other 510(k) Applications for this Company
Contact	ROGER GRAY Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	HLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2013
Decision Date	04/23/2014
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