FDA 510(k) Application Details - K992606

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K992606
Device Name	Ophthalmoscope, Ac-Powered
Applicant	CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 US Other 510(k) Applications for this Company
Contact	KEN SHADOFF 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	08/03/1999
Decision Date	06/21/2000
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