510(k) DEN200076
- Device
- ORi
- Applicant
- Masimo Corporation
- 510(k) number
- DEN200076
- Product code
- QWE
- Decision
- Unknown (DENG)
- Decision date
- 2023-10-12
- Date received
- 2020-12-21
- Regulation
- 870.2720
- Classification name
- Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Linus Park
- Address
- 52 Discovery Irvine CA US 92618 92618
FDA Registration Numbers#
- 3027256461
- 3004415095
- 3019388613
- 3011353843
Source Documents#
510(k) summary PDF not indicated by FDA