FDA 510(k) Application Details - K122938

Device Classification Name	System, Image Management, Ophthalmic   More FDA Info for this Device
510(K) Number	K122938
Device Name	System, Image Management, Ophthalmic
Applicant	CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE DUBLIN, CA 94568 US Other 510(k) Applications for this Company
Contact	JUDY BRIMACOMBE Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	NFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2012
Decision Date	11/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review