Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LifeSignals ECG Remote Monitoring Patch Platform

K-Number: K200690 · 2020-07-15

ApplicantLifesignals, Inc.
Decision Date2020-07-15
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeSignals ECG Remote Monitoring Patch 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 2020-07-15 under 510(k) number K200690. 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 ECG Remote Monitoring Patch Platform?

LifeSignals ECG Remote Monitoring Patch Platform is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Lifesignals, Inc.. The 510(k) number is K200690.

When did LifeSignals ECG Remote Monitoring Patch Platform receive FDA 510(k) clearance?

LifeSignals ECG Remote Monitoring Patch Platform received FDA 510(k) clearance on 2020-07-15, under 510(k) number K200690.

Who is the listed applicant for LifeSignals ECG Remote Monitoring Patch 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 ECG Remote Monitoring Patch Platform?

The FDA product code for LifeSignals ECG Remote Monitoring Patch Platform is DRG.

Related Clinical Trials

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.

NCT06243029A Study to Assess Multidomain Endpoints of an ECG PatchCOMPLETEDNCT07699874Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure : A Pilot Study Using a New Wearable SensorACTIVE_NOT_RECRUITINGNCT07736066Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart SurgeryCOMPLETEDNCT07785700Home-Based Functional Electrical Stimulation for Lower Limb Rehabilitation in Stroke Patients.NOT_YET_RECRUITING

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)K202868LifeSignals Multi-Parameter Remote Monitoring 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

View on FDA Database →

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

↑