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510(k) K193179

Device
EV1000 Clinical Platform
Applicant
Edwards Lifesciences, LLC
510(k) number
K193179
Product code
DXG  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-17
Date received
2019-11-18
Regulation
870.1435
Classification name
Computer, Diagnostic, Pre-programmed, Single-function
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jamie Byun
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.2026-02-13
K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical2025-09-26
K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical2023-12-20
K212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.2021-11-23
K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE2020-04-30
K190955Hypotension Decision AssistDirected Systems, Ltd.2019-11-27
K181372ArgosRetia Medical, LLC2018-12-13
K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE2018-01-18
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

Legacy Summary#

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FDA Review#

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