FDA 510(k) Application Details - K190848

Device Classification Name	More FDA Info for this Device
510(K) Number	K190848
Device Name	JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
Applicant	Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing 210036 CN Other 510(k) Applications for this Company
Contact	Zilong Liang 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	04/01/2019
Decision Date	05/14/2019
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