FDA 510(k) Application Details - K241049

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K241049
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Canon Inc. 9-1, Imaikami-cho, Nakahara-ku Kawasaki 2118501 JP Other 510(k) Applications for this Company
Contact	Shigeo Watanabe 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	04/17/2024
Decision Date	05/15/2024
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