FDA 510(k) Application Details - K973218

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K973218
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	NIDEK, INC. 47651 WESTINGHOUSE DR. FREMONT, CA 94539 US Other 510(k) Applications for this Company
Contact	KEN KATO 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	08/27/1997
Decision Date	11/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review