Esprit Nova— 510(k) K182227

Substantially Equivalent

Neurozone Msh Incorporated

FDA 510(k) clearance K182227 for Esprit Nova, Substantially Equivalent on 2019-01-17. Applicant: Neurozone Msh Incorporated. Device class: 2.

Clearance details

Applicant
Neurozone Msh Incorporated
Product code
Code OLZ
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dundas, CA
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