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 a medical device manufactured by Neurozone Msh Incorporated. It received FDA 510(k) clearance on 2019-01-17 under approval 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. It is manufactured by Neurozone Msh Incorporated. The 510(k) number is K182227.
When was Esprit Nova approved by the FDA?
Esprit Nova received FDA 510(k) clearance on 2019-01-17, under approval number K182227.
What company makes Esprit Nova?
Esprit Nova is manufactured by Neurozone Msh Incorporated.
What is the FDA product code for Esprit Nova?
The FDA product code for Esprit Nova is OLZ.
Related Devices (Code: OLZ)
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.