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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K172969
Device Name Essence 55S Large Monitor System
Applicant
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Shenbei New District
# 18-6b, Yaoyang Rd., Huishan Economic Development Area
Shenyang,  CN
Applicant Contact Fu Ailing
Correspondent
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Shenbei New District
# 18-6b, Yaoyang Rd., Huishan Economic Development Area
Shenyang,  CN
Correspondent Contact Fu Ailing
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received09/26/2017
Decision Date 01/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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