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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for polysomnograph with electroencephalograph
510(k) Number K182227
Device Name Esprit Nova
Applicant
Neurozone MSH Incorporated
17 Lantern Lane
Dundas,  CA L9H 6N9
Applicant Contact Daniel Ramirez Rodriguez
Correspondent
Neurozone MSH Incorporated
17 Lantern Lane
Dundas,  CA L9H 6N9
Correspondent Contact Daniel Ramirez Rodriguez
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received08/16/2018
Decision Date 01/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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