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FDA 510(k)

UbiqVue™ 2A Multi-parameter System (UX2550)

K-Number: K242018 · 2024-11-12

ApplicantLifesignals, Inc.
Decision Date2024-11-12
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UbiqVue™ 2A Multi-parameter System (UX2550) is the device name listed in this FDA 510(k) record. The listed applicant is Lifesignals, Inc.. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242018. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UbiqVue™ 2A Multi-parameter System (UX2550)?

UbiqVue™ 2A Multi-parameter System (UX2550) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Lifesignals, Inc.. The 510(k) number is K242018.

When did UbiqVue™ 2A Multi-parameter System (UX2550) receive FDA 510(k) clearance?

UbiqVue™ 2A Multi-parameter System (UX2550) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242018.

Who is the listed applicant for UbiqVue™ 2A Multi-parameter System (UX2550)?

The FDA 510(k) record lists Lifesignals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UbiqVue™ 2A Multi-parameter System (UX2550)?

The FDA product code for UbiqVue™ 2A Multi-parameter System (UX2550) is DRG.

Other records listing Lifesignals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)K202868LifeSignals Multi-Parameter Remote Monitoring PlatformK200690LifeSignals ECG Remote Monitoring Patch Platform

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK241101BioButton SystemBiointellisense, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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