510(k) DEN200076
DEN200076 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "ORi". The FDA issued a decision of De Novo Granted on October 12, 2023. The device falls under product code QWE (Hyperoxia Monitoring Device Adjunct To Pulse Oximetry), a Class II device regulated under 21 CFR 870.2720. Masimo Corporation has at least 10 other 510(k) clearances on record.
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.