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FDA 510(k)

PulsioFlex Monitoring System

K-Number: K172259 · 2018-01-18

ApplicantPulsion Medical Systems SE
Decision Date2018-01-18
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PulsioFlex Monitoring System is a medical device manufactured by Pulsion Medical Systems SE. It received FDA 510(k) clearance on 2018-01-18 under approval number K172259. 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?

PulsioFlex Monitoring System is a medical device that received FDA 510(k) clearance on 2018-01-18. It is manufactured by Pulsion Medical Systems SE. The 510(k) number is K172259.

When was PulsioFlex Monitoring System approved by the FDA?

PulsioFlex Monitoring System received FDA 510(k) clearance on 2018-01-18, under approval number K172259.

What company makes PulsioFlex Monitoring System?

PulsioFlex Monitoring System is manufactured by Pulsion Medical Systems SE.

What is the FDA product code for PulsioFlex Monitoring System?

The FDA product code for PulsioFlex Monitoring System is DXG.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Pulsion Medical Systems SE

K171620PiCCO Catheter K192169PulsioFlex Monitoring System with ProAQT Sensor

Related Devices (Code: DXG)

K152935LiDCOunity MonitorLidco, Ltd. K163334LiDCOunity v2 Hemodynamic MonitorLidco, Ltd. K181372ArgosRetia Medical, LLC K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC K190955Hypotension Decision AssistDirected Systems, Ltd. K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE

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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