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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 isocapnic ventilation device
De Novo Number DEN170044
Device Name ClearMate
Requester
thornhill research, inc.
210 dundas st. w.
toronto,  CA m5g 2e8
Contact kipton lade
Regulation Number868.5480
Classification Product Code
QFB  
Date Received08/18/2017
Decision Date 03/14/2019
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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