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

FDA 510(k)

Esprit Nova

K-Number: K182227 · 2019-01-17

ApplicantNeurozone Msh Incorporated
Decision Date2019-01-17
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Esprit Nova is the device name listed in this FDA 510(k) record. The listed applicant is Neurozone Msh Incorporated. It received FDA 510(k) clearance on 2019-01-17 under 510(k) number K182227. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esprit Nova?

Esprit Nova is a medical device that received FDA 510(k) clearance on 2019-01-17. The listed applicant is Neurozone Msh Incorporated. The 510(k) number is K182227.

When did Esprit Nova receive FDA 510(k) clearance?

Esprit Nova received FDA 510(k) clearance on 2019-01-17, under 510(k) number K182227.

Who is the listed applicant for Esprit Nova?

The FDA 510(k) record lists Neurozone Msh Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esprit Nova?

The FDA product code for Esprit Nova is OLZ.

Related Devices (Code: OLZ)

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.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical Ehf

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.

↑