QWE

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Product code

QWE

Device name

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Device class

Class 2

21 CFR

21 CFR 870.2720

Medical specialty

Anesthesiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-12.