510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QWEClass II

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

21 CFR 870.2720 / Anesthesiology
FDA source (opens on fda.gov)

QWE is the FDA product code for Hyperoxia Monitoring Device Adjunct To Pulse Oximetry, a class II device type, regulated under 21 CFR 870.2720. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWE
Device name
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
FDA 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.
Regulation
21 CFR 870.2720
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QWE

By decision year
1 clearance under product code QWE with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWE by decision year
YearClearances
20231

Applicants with the most clearances

Product code QWE
Applicants holding the most 510(k) clearances under product code QWE
ApplicantClearances
Masimo Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code