Cleared Traditional

Cogent? Hemodynamic Monitoring System; Cogent? HMS

K232048 · Icu Medical · Cardiovascular
Dec 2023
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K232048 is an FDA 510(k) clearance for the Cogent? Hemodynamic Monitoring System; Cogent? HMS, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Icu Medical (San Clemente, US). The FDA issued a Cleared decision on December 20, 2023, 163 days after receiving the submission on July 10, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K232048 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2023
Decision Date December 20, 2023
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXG — Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1435

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