Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
The hyperoxia monitoring device adjunct to pulse oximetry (product code QWE) is an Anesthesiology device (regulation 870.2720) that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring. Classified as Class 2, it requires 510(k) premarket notification. The device serves as a supplementary monitoring tool alongside standard pulse oximetry and is neither an implant nor life-sustaining.
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Basic Information
- Product Code
- QWE
- Device Class
- FDA class 2
- Regulation Number
- 870.2720
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200076 | ORi | Oct 12, 2023 | Unknown | Masimo Corporation |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.