FDA 510(k) Application Details - K182539

Device Classification Name	More FDA Info for this Device
510(K) Number	K182539
Device Name	2MP Color LCD Monitor CL-R211
Applicant	JVC Kenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama 221-0022 JP Other 510(k) Applications for this Company
Contact	Masafumi Yugami Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2018
Decision Date	10/03/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review