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510(k) DEN200076

ORi by Masimo Corporation — Product Code QWE

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 12, 2023
Date Received
December 21, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Device Class
Class II
Regulation Number
870.2720
Review Panel
AN
Submission Type

A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.

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