PulsioFlex Monitoring System with ProAQT Sensor— 510(k) K192169

Substantially Equivalent

Pulsion Medical Systems SE

FDA 510(k) clearance K192169 for PulsioFlex Monitoring System with ProAQT Sensor, Substantially Equivalent on 2020-04-30. Applicant: Pulsion Medical Systems SE.

Clearance details

Applicant
Pulsion Medical Systems SE
Product code
Code DXG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Feldkirchen, DE
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.