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

Name: FDA 510(k) clearance K192169
Creator: U.S. Food and Drug Administration
Published: 2020-04-30

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. Device class: 2.

Clearance details

Applicant: Pulsion Medical Systems SE
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2019-08-09
Decision date: 2020-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirchen, DE

Download summary PDF View on FDA.gov ↗

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