Essence 55S Large Monitor System

Display, Cathode-ray Tube, Medical

Shenyang Torch-Bigtide Digital Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenyang Torch-bigtide Digital Technology Co., Ltd. with the FDA for Essence 55s Large Monitor System.

Pre-market Notification Details

Device IDK172969
510k NumberK172969
Device Name:Essence 55S Large Monitor System
ClassificationDisplay, 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
ContactFu Ailing
CorrespondentFu Ailing
Shenyang Torch-Bigtide Digital Technology Co., Ltd. Shenbei New District NO. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang,  CN
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-26
Decision Date2018-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970438060003 K172969 000

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