Clearance Summary
PulsioFlex Monitoring System with ProAQT Sensor received FDA 510(k) clearance under submission number K192169, sponsored by Pulsion Medical Systems SE. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-04-30.
- Submission: K192169
- Applicant / Sponsor: Pulsion Medical Systems SE
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 2020-04-30
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.