FDA 510(k)

Essence 55S Large Monitor System

Número K: K172969 · 2018-01-26

RequerenteShenyang Torch-Bigtide Digital Technology Co., Ltd.

Data da decisão2018-01-26

Código do produtoDXJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Essence 55S Large Monitor System is the device name listed in this FDA 510(k) record. The listed applicant is Shenyang Torch-Bigtide Digital Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K172969. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Essence 55S Large Monitor System?

Essence 55S Large Monitor System is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Shenyang Torch-Bigtide Digital Technology Co., Ltd.. The 510(k) number is K172969.

When did Essence 55S Large Monitor System receive FDA 510(k) clearance?

Essence 55S Large Monitor System received FDA 510(k) clearance on 2018-01-26, under 510(k) number K172969.

Who is the listed applicant for Essence 55S Large Monitor System?

The FDA 510(k) record lists Shenyang Torch-Bigtide Digital Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Essence 55S Large Monitor System?

The FDA product code for Essence 55S Large Monitor System is DXJ.

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Outros registros que listam Shenyang Torch-Bigtide Digital Technology Co., Ltd. como candidato(a)

K201162Essence 55SP Large Monitor System

Dispositivos Relacionados (Código: DXJ)

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