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FDA 510(k)

PulsioFlex Monitoring System with ProAQT Sensor

K-Number: K192169 · 2020-04-30

ApplicantPulsion Medical Systems SE
Decision Date2020-04-30
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PulsioFlex Monitoring System with ProAQT Sensor is a medical device manufactured by Pulsion Medical Systems SE. It received FDA 510(k) clearance on 2020-04-30 under approval number K192169. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PulsioFlex Monitoring System with ProAQT Sensor?

PulsioFlex Monitoring System with ProAQT Sensor is a medical device that received FDA 510(k) clearance on 2020-04-30. It is manufactured by Pulsion Medical Systems SE. The 510(k) number is K192169.

When was PulsioFlex Monitoring System with ProAQT Sensor approved by the FDA?

PulsioFlex Monitoring System with ProAQT Sensor received FDA 510(k) clearance on 2020-04-30, under approval number K192169.

What company makes PulsioFlex Monitoring System with ProAQT Sensor?

PulsioFlex Monitoring System with ProAQT Sensor is manufactured by Pulsion Medical Systems SE.

What is the FDA product code for PulsioFlex Monitoring System with ProAQT Sensor?

The FDA product code for PulsioFlex Monitoring System with ProAQT Sensor is DXG.

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Related PubMed Literature

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Other Devices by Pulsion Medical Systems SE

K171620PiCCO Catheter K172259PulsioFlex Monitoring System

Related Devices (Code: DXG)

K152935LiDCOunity MonitorLidco, Ltd. K163334LiDCOunity v2 Hemodynamic MonitorLidco, Ltd. K181372ArgosRetia Medical, LLC K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC K190955Hypotension Decision AssistDirected Systems, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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