K172259

Substantially Equivalent

PulsioFlex Monitoring System

Applicant: Pulsion Medical Systems SE
Product code: DXG
Advisory panel: Cardiovascular
Date received: 2017-07-27
Decision date: 2018-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirchen, DE

Download summary PDF View on FDA.gov ↗

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