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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 hyperoxia monitoring device adjunct to pulse oximetry
De Novo Number DEN200076
Device Name ORi
Requester
masimo corporation
52 discovery
irvine,  CA  92618
Contact linus park
Regulation Number870.2720
Classification Product Code
QWE  
Date Received12/21/2020
Decision Date 10/12/2023
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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