Cleared Traditional

LifeSignals Multi-Parameter Remote Monitoring Platform

K202868 · Lifesignals, Inc. · Cardiovascular

Jul 2021

Decision

296d

Days

Class 2

Risk

About This 510(k) Submission

K202868 is an FDA 510(k) clearance for the LifeSignals Multi-Parameter Remote Monitoring 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 21, 2021, 296 days after receiving the submission on September 28, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K202868 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2020
Decision Date	July 21, 2021
Days to Decision	296 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