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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K151361
Device Name Nox RIP Belts & Cables
Applicant
Nox Medical Ehf
Katrinartuni 2
Reykjavik,  IS 105
Applicant Contact KOLBRUN E OTTOSDOTTIR
Correspondent
Nox Medical Ehf
Katrinartuni 2
Reykjavik,  IS 105
Correspondent Contact KOLBRUN E OTTOSDOTTIR
Regulation Number868.2375
Classification Product Code
MNR  
Date Received05/21/2015
Decision Date 11/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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