Devices · Masimo Corporation

Masimo SafetyNet

Masimo Corporation is listed for Masimo SafetyNet (DEN200011). The FDA list gives March 31, 2023 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QVT as “Monitor For Opioid Induced Impairment Of Oxygenation”: 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 openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200011

Official FDA database record

Date of final decision

March 31, 2023

Company on the FDA list

Masimo Corporation

Lead panel

Anesthesiology

Primary product code

QVT

openFDA device name for the code

Monitor For Opioid Induced Impairment Of Oxygenation

Device class

2

Regulation number

868.2250

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned