Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

K-Number: K232048 · 2023-12-20

ApplicantIcu Medical
Decision Date2023-12-20
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232048. 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 Cogent™ Hemodynamic Monitoring System; Cogent™ HMS?

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Icu Medical. The 510(k) number is K232048.

When did Cogent™ Hemodynamic Monitoring System; Cogent™ HMS receive FDA 510(k) clearance?

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232048.

Who is the listed applicant for Cogent™ Hemodynamic Monitoring System; Cogent™ HMS?

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

What is the FDA product code for Cogent™ Hemodynamic Monitoring System; Cogent™ HMS?

The FDA product code for Cogent™ Hemodynamic Monitoring System; Cogent™ HMS is DXG.

Other records listing Icu Medical 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.

K252130LifeShield Infusion Safety Software SuiteK252006OTTO™ Disinfecting CapK251980ClaveQS™ BagK250616Clave™ Neutral-Displacement Needlefree ConnectorsK242117LifeShield Infusion Safety Software SuiteK242115Plum Duo™ Precision IV Pump

View all 19 devices →

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 MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLCK190955Hypotension 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.

↑