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FDA 510(k)

LifeSignals Multi-Parameter Remote Monitoring Platform

K-Number: K202868 · 2021-07-21

ApplicantLifesignals, Inc.
Decision Date2021-07-21
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeSignals Multi-Parameter Remote Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Lifesignals, Inc.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K202868. 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 LifeSignals Multi-Parameter Remote Monitoring Platform?

LifeSignals Multi-Parameter Remote Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Lifesignals, Inc.. The 510(k) number is K202868.

When did LifeSignals Multi-Parameter Remote Monitoring Platform receive FDA 510(k) clearance?

LifeSignals Multi-Parameter Remote Monitoring Platform received FDA 510(k) clearance on 2021-07-21, under 510(k) number K202868.

Who is the listed applicant for LifeSignals Multi-Parameter Remote Monitoring Platform?

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 LifeSignals Multi-Parameter Remote Monitoring Platform?

The FDA product code for LifeSignals Multi-Parameter Remote Monitoring Platform 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)K242018UbiqVue™ 2A Multi-parameter System (UX2550)K200690LifeSignals 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 LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

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

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