Cleared Traditional

Essence 55SP Large Monitor System

K201162 · Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Cardiovascular

Aug 2020

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K201162 is an FDA 510(k) clearance for the Essence 55SP Large Monitor System, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Shenyang Torch-Bigtide Digital Technology Co., Ltd. (Shenyang, CN). The FDA issued a Cleared decision on August 27, 2020, 119 days after receiving the submission on April 30, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number	K201162 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2020
Decision Date	August 27, 2020
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF