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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 K241960
Device Name DeepRESP
Applicant
Nox Medical ehf
Katrinartuni 2
IS - 105
Reykjavik,  IS
Applicant Contact Kolbrún E Ottósdóttir
Correspondent
RQM+
2790 Mosside Blvd #800
Monroeville,  PA  15146
Correspondent Contact Hrishikesh Gadagkar
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received07/03/2024
Decision Date 03/14/2025
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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