FDA 510(k) Application Details - K043222

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K043222
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE DUBLIN, CA 94568-7562 US Other 510(k) Applications for this Company
Contact	R. MICHAEL CROMPTON Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2004
Decision Date	02/14/2005
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