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 a medical device manufactured by Icu Medical. It received FDA 510(k) clearance on 2023-12-20 under approval 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. It is manufactured by Icu Medical. The 510(k) number is K232048.
When was Cogent Hemodynamic Monitoring System; Cogent HMS approved by the FDA?
Cogent Hemodynamic Monitoring System; Cogent HMS received FDA 510(k) clearance on 2023-12-20, under approval number K232048.
What company makes Cogent Hemodynamic Monitoring System; Cogent HMS?
Cogent Hemodynamic Monitoring System; Cogent HMS is manufactured by Icu Medical.
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.
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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.