FDA.reportPublic FDA data

510(k) K253092

Device
Argos Infinity (Rev. 1.0)
Applicant
Retia Medical Systems, Inc.
510(k) number
K253092
Product code
DXG
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-13
Date received
2025-09-23
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
N

Applicant Contact#

Contact
Alexander Markovic
Address
333 Westchestaer Ave. Suite 102w White Plains NY US 10604 10604

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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