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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 K124062
Device Name QDC-PRO, AND NOX-RIP
Applicant
NOX MEDICAL
VATNAGORDUM 18
REYKJAVIK,  IS 104
Applicant Contact KOLBRUN E OTTOSDOTTIR
Correspondent
NOX MEDICAL
VATNAGORDUM 18
REYKJAVIK,  IS 104
Correspondent Contact KOLBRUN E OTTOSDOTTIR
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/31/2012
Decision Date 07/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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