Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2021-11-10 under approval 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. It is manufactured by Livanova Deutschland, GmbH. The 510(k) number is K212003.

When was ESSENZ Patient Monitor approved by the FDA?

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

What company makes ESSENZ Patient Monitor?

ESSENZ Patient Monitor is manufactured by Livanova Deutschland, GmbH.

What is the FDA product code for ESSENZ Patient Monitor?

The FDA product code for ESSENZ Patient Monitor is DXJ.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT05673408 NIBP Validation Study RECRUITING NCT07599592 Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor RECRUITING

Other Devices by Livanova Deutschland, GmbH

K191402Heater-Cooler System 3T K210130Stockert S5 System K202154B-Capta K220635Heater-Cooler System 3T K232291Essenz HLM, Essenz ILBM K221373Essenz HLM

View all 7 devices →

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.

↑