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FDA 510(k)

Essence 55SP Large Monitor System

K-Number: K201162 · 2020-08-27

ApplicantShenyang Torch-Bigtide Digital Technology Co., Ltd.
Decision Date2020-08-27
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Essence 55SP Large Monitor System is a medical device manufactured by Shenyang Torch-Bigtide Digital Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-27 under approval number K201162. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Essence 55SP Large Monitor System?

Essence 55SP Large Monitor System is a medical device that received FDA 510(k) clearance on 2020-08-27. It is manufactured by Shenyang Torch-Bigtide Digital Technology Co., Ltd.. The 510(k) number is K201162.

When was Essence 55SP Large Monitor System approved by the FDA?

Essence 55SP Large Monitor System received FDA 510(k) clearance on 2020-08-27, under approval number K201162.

What company makes Essence 55SP Large Monitor System?

Essence 55SP Large Monitor System is manufactured by Shenyang Torch-Bigtide Digital Technology Co., Ltd..

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

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

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Other Devices by Shenyang Torch-Bigtide Digital Technology Co., Ltd.

K172969Essence 55S Large Monitor System

Related Devices (Code: DXJ)

K162012CARESCAPE Central Station V2GE Healthcare K170460Sorin ConnectSorin Group Deutschland GmbH K170537Nexxis OR, NexxisBarco N.V. K161880NIVR58-T kitBarco N.V. K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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