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FDA 510(k)

Cogent Hemodynamic Monitoring System

K-Number: K152006 · 2016-05-05

ApplicantIcu Medical, Inc.
Decision Date2016-05-05
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cogent Hemodynamic Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K152006. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cogent Hemodynamic Monitoring System?

Cogent Hemodynamic Monitoring System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Icu Medical, Inc.. The 510(k) number is K152006.

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

Cogent Hemodynamic Monitoring System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K152006.

Who is the listed applicant for Cogent Hemodynamic Monitoring System?

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

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

The FDA product code for Cogent Hemodynamic Monitoring System is DXQ.

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Related Devices (Code: DXQ)

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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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