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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 a medical device manufactured by Lifesignals, Inc.. It received FDA 510(k) clearance on 2021-07-21 under approval 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. It is manufactured by Lifesignals, Inc.. The 510(k) number is K202868.

When was LifeSignals Multi-Parameter Remote Monitoring Platform approved by the FDA?

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

What company makes LifeSignals Multi-Parameter Remote Monitoring Platform?

LifeSignals Multi-Parameter Remote Monitoring Platform is manufactured by Lifesignals, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Lifesignals, Inc.

K200690LifeSignals ECG Remote Monitoring Patch Platform K242018UbiqVue™ 2A Multi-parameter System (UX2550)

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Official Source

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