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510(k) K232048

Device
Cogent? Hemodynamic Monitoring System; Cogent? HMS
Applicant
Icu Medical
510(k) number
K232048
Product code
DXG
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-20
Date received
2023-07-10
Regulation
870.1435
Classification name
Computer, Diagnostic, Pre-Programmed, Single-Function
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Diane Stockman
Address
915 Calle Amanecer San Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K163334LiDCOunity v2 Hemodynamic MonitorLidco, Ltd.2017-06-05
K152935LiDCOunity MonitorLidco, Ltd.2016-03-17
K134051TRANSONIC ELSA SYSTEMTransonic Systems, Inc.2015-01-29
K134035TRANSONIC HCM 103 SYSTEMTransonic Systems, Inc.2014-09-17
K140017TRANSONIC HCM 102 SYSTEMTransonic Systems, Inc.2014-09-16
K132892TEBCO-WBomed, Inc.2014-08-01
K131588VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOREdwards Lifesciences, LLC2014-05-22