FDA 510(k) Application Details - K172969

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K172969
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	Shenyang Torch-Bigtide Digital Technology Co., Ltd. Shenbei New District NO. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang 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	09/26/2017
Decision Date	01/26/2018
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