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510(k) DEN200011

Masimo SafetyNet by Masimo Corporation — Product Code QVT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 31, 2023
Date Received
February 19, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor For Opioid Induced Impairment Of Oxygenation
Device Class
Class II
Regulation Number
868.2250
Review Panel
AN
Submission Type

A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose

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