Cleared Traditional

K200690 - LifeSignals ECG Remote Monitoring Patch Platform
(FDA 510(k) Clearance)

K200690 · Lifesignals, Inc. · Cardiovascular

Jul 2020

Decision

121d

Days

Class 2

Risk

K200690 is an FDA 510(k) clearance for the LifeSignals ECG Remote Monitoring Patch Platform, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Lifesignals, Inc. (Fremont, US). The FDA issued a Cleared decision on July 15, 2020, 121 days after receiving the submission on March 16, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K200690 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2020
Decision Date	July 15, 2020
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910