FDA 510(k) Application Details - K102013

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K102013
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	CANON, INC.-MEDICAL EQUIPMENT GROUP 3F 2-17-6 AKEBONO-CHO TACHIKAWA-SHI, TOKYO 190-0012 JP Other 510(k) Applications for this Company
Contact	KOJI KUBO 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	07/16/2010
Decision Date	10/29/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review