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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 the device name listed in this FDA 510(k) record. The listed applicant is Pulsion Medical Systems SE. It received FDA 510(k) clearance on 2020-04-30 under 510(k) 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. The listed applicant is Pulsion Medical Systems SE. The 510(k) number is K192169.

When did PulsioFlex Monitoring System with ProAQT Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for PulsioFlex Monitoring System with ProAQT Sensor?

The FDA 510(k) record lists Pulsion Medical Systems SE as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Pulsion Medical Systems SE as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171620PiCCO CatheterK172259PulsioFlex Monitoring System

Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K193179EV1000 Clinical PlatformEdwards Lifesciences, LLCK190955Hypotension Decision AssistDirected Systems, Ltd.

Official Source

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

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