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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 St., NW
Washington, Dc,  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
Predetermined Change
Control Plan Authorized		 No
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