Clearance Summary
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) received FDA 510(k) clearance under submission number K211561, sponsored by Covidien, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-12-05.
- Submission: K211561
- Applicant / Sponsor: Covidien, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2021-12-05
Classification & Regulation
This clearance is catalogued under FDA product code MUD and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.