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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
Recalls CDRH Recalls
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