FDA 510(k) Application Details - K972440

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K972440
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU TOKYO 162-0056 JP Other 510(k) Applications for this Company
Contact	MASAO SUGASAWA 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	06/30/1997
Decision Date	09/30/1997
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