DEN200076
- 510(k) number
- DEN200076
- Device name
- ORi
- Applicant
- Masimo Corporation CA · US
- Product code
- QWE — Hyperoxia Monitoring Device Adjunct To Pulse Oximetr
- Decision date
- 2023-10-12
- Date received
- 2020-12-21
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Anesthesiology
Official FDA record: DEN200076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.