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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 monitor for opioid induced impairment of oxygenation
De Novo Number DEN200011
Device Name Masimo SafetyNet
Requester
masimo corporation
52 discovery
irvine,  CA  91628
Contact linus park
Regulation Number868.2250
Classification Product Code
QVT  
Date Received02/19/2020
Decision Date 03/31/2023
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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