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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K260585
Device Name Noxturnal Web
Applicant
Nox Medical Ehf
Katrinartuni 2, Is - 105
Reykjavik,  IS
Applicant Contact Elísabet Finnbogadóttir
Correspondent
RQM+
5000 Centregreen Way
Suite 100
Cary,  NC  27513
Correspondent Contact Hrishikesh Gadagkar
Regulation Number882.1400
Classification Product Code
OLV  
Date Received02/20/2026
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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