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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 high flow/high velocity humidified oxygen delivery device
De Novo Number DEN170001
Device Name Precision Flow® HVNI
Requester
vapotherm, inc.
22 industrial dr.
exeter,  NH  03833
Contact som kovvuri
Regulation Number868.5454
Classification Product Code
QAV  
Date Received01/03/2017
Decision Date 04/10/2018
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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