510(k) DEN200011
DEN200011 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo SafetyNet". The FDA issued a decision of De Novo Granted on March 31, 2023. The device falls under product code QVT (Monitor For Opioid Induced Impairment Of Oxygenation), a Class II device regulated under 21 CFR 868.2250. Masimo Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 31, 2023
- Date Received
- February 19, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor For Opioid Induced Impairment Of Oxygenation
- Device Class
- Class II
- Regulation Number
- 868.2250
- Review Panel
- AN
- Submission Type
A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose