FDA 510(k) Application Details - K201162

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K201162
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	Shenyang Torch-Bigtide Digital Technology Co., Ltd. No. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang 110164 CN Other 510(k) Applications for this Company
Contact	Fu Ailing Other 510(k) Applications for this Contact
Regulation Number	870.2450   More FDA Info for this Regulation Number
Classification Product Code	DXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2020
Decision Date	08/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review