FDA 510(k) Application Details - K063378

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K063378
Device Name	Ophthalmoscope, Ac-Powered
Applicant	CARL ZEISS MEDITEC INC 5160 HACIENDA DR. DUBLIN, CA 94568 US Other 510(k) Applications for this Company
Contact	JUDITH A BRIMACOMBE 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	11/08/2006
Decision Date	01/26/2007
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