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FDA 510(k)

ESSENZ Patient Monitor

K-Number: K212003 · 2021-11-10

ApplicantLivanova Deutschland, GmbH
Decision Date2021-11-10
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESSENZ Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212003. 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 ESSENZ Patient Monitor?

ESSENZ Patient Monitor is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K212003.

When did ESSENZ Patient Monitor receive FDA 510(k) clearance?

ESSENZ Patient Monitor received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212003.

Who is the listed applicant for ESSENZ Patient Monitor?

The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESSENZ Patient Monitor?

The FDA product code for ESSENZ Patient Monitor is DXJ.

Other records listing Livanova Deutschland, GmbH as applicant

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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.

K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios 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

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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