Cleared Traditional

K172969 - Essence 55S Large Monitor System
(FDA 510(k) Clearance)

K172969 · Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Cardiovascular

Jan 2018

Decision

122d

Days

Class 2

Risk

K172969 is an FDA 510(k) clearance for the Essence 55S Large Monitor System. This device is classified as 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 January 26, 2018, 122 days after receiving the submission on September 26, 2017.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number	K172969 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2017
Decision Date	January 26, 2018
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF