Masimo SafetyNet
FDA 510(k) clearance DEN200011 · decided 2023-03-31
Clearance details
- K-number
- DEN200011
- Device name
- Masimo SafetyNet
- Applicant
- Masimo Corporation
- Decision
- Unknown
- Date received
- 2020-02-19
- Decision date
- 2023-03-31
- Days to decision
- 1136 days
- Clearance type
- Direct
- Product code
- QVT
- Device class
- 2
- Regulation number
- 868.2250
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.