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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 K192469
Device Name Nox Sleep System
Applicant
Nox Medical
Katrinartuni 2
Reykjavik,  IS 105
Applicant Contact Kolburn E Ottosdottir
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
KZM  
Date Received09/09/2019
Decision Date 11/13/2019
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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