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 a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2016-05-05 under approval 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. It is manufactured by Icu Medical, Inc.. The 510(k) number is K152006.
When was Cogent Hemodynamic Monitoring System approved by the FDA?
Cogent Hemodynamic Monitoring System received FDA 510(k) clearance on 2016-05-05, under approval number K152006.
What company makes Cogent Hemodynamic Monitoring System?
Cogent Hemodynamic Monitoring System is manufactured by Icu Medical, Inc..
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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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.