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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 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 2020-08-27 under 510(k) 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. The listed applicant is Shenyang Torch-Bigtide Digital Technology Co., Ltd.. The 510(k) number is K201162.

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

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

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

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

Other records listing Shenyang Torch-Bigtide Digital Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172969Essence 55S Large Monitor System

Related Devices (Code: DXJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.

Official Source

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

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