Essence 55SP 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 55sp Large Monitor System.

Pre-market Notification Details

Device IDK201162
510k NumberK201162
Device Name:Essence 55SP Large Monitor System
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant Shenyang Torch-Bigtide Digital Technology Co., Ltd. No. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang,  CN 110164
ContactFu Ailing
CorrespondentFu Ailing
Shenyang Torch-Bigtide Digital Technology Co., Ltd. No. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang,  CN 110164
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-30
Decision Date2020-08-27

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.