UbiqVue 2A Multi-parameter System (UX2550)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242018

Identifiers

510(k) Number: K242018 FDA 510(k)
FDA Product Code: DRG FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.2910 FDA 510(k)
Regulation Number: 870.2910 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The UbiqVue 2A Multi-parameter System (UX2550) is a Transmitter and Receiver, Physiological Signal, Radiofrequency device. It monitors and transmits multiple physiological parameters, enabling continuous remote patient monitoring for cardiovascular assessment.

This system is designed for use in clinical settings, including hospitals and outpatient facilities, and is intended for single-use or reusable applications depending on the attached sensors. It operates within Class II regulatory classification and has received FDA 510K clearance and MDR authorization. The device supports various signal transmissions and is compatible with standard medical monitoring environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K242018	Class II	Active

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Manufacturer

Manufacturer: LifeSignals, Inc.

Sources (2)

FDA 510(k) K242018 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026