FDA 510(k) Application Details - K200161

Device Classification Name	More FDA Info for this Device
510(K) Number	K200161
Device Name	3MP Monochrome Digital Mammography LCD Monitor MS-S300
Applicant	Jvckenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama 221-0022 JP Other 510(k) Applications for this Company
Contact	Hideki Tengeiji 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	01/22/2020
Decision Date	02/21/2020
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