510(k) DEN200011
- Device
- Masimo SafetyNet
- Applicant
- Masimo Corporation
- 510(k) number
- DEN200011
- Product code
- QVT
- Decision
- Unknown (DENG)
- Decision date
- 2023-03-31
- Date received
- 2020-02-19
- Regulation
- 868.2250
- Classification name
- Monitor For Opioid Induced Impairment Of Oxygenation
- 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 91628 91628
Source Documents#
510(k) summary PDF not indicated by FDA