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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 K082113
Device Name NOX T3, NOXTURNAL (PC APPLICATION)
Applicant
Nox Medical
Keldnaholti
Reykjavik,  IS 112
Applicant Contact KOLBRUN E OTTOSDOTTIR
Correspondent
Nox Medical
Keldnaholti
Reykjavik,  IS 112
Correspondent Contact KOLBRUN E OTTOSDOTTIR
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/28/2008
Decision Date 11/07/2008
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
Recalls CDRH Recalls
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