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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name closed loop auto titration device for oral appliances
De Novo Number DEN170090
Device Name MATRx plus
Requester
zephyr sleep technologies
610a 70 ave. se
calgary,  CA t2h-2j6
Contact sabrina bruehlmann
Regulation Number872.5571
Classification Product Code
QCJ  
Date Received12/21/2017
Decision Date 08/23/2018
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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