Cleared Traditional

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

K170565 · Lifewatch Services, Inc. · Cardiovascular

Aug 2017

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K170565 is an FDA 510(k) clearance for the LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L, a Outpatient Cardiac Telemetry (Class II — Special Controls, product code QYX), submitted by Lifewatch Services, Inc. (Rosemont, US). The FDA issued a Cleared decision on August 1, 2017, 155 days after receiving the submission on February 27, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K170565 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2017
Decision Date	August 01, 2017
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QYX — Outpatient Cardiac Telemetry
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1025
Definition	Devices Are Intended To Continuously Record And Analyze Electrocardiograms For Automatic Detection And Recording Of Cardiac Electrical Activity In An Outpatient Setting. Detected, Notifiable Events Are Transmitted To The Prescribing Clinician During The Monitoring Period By A 24/7 Attended Analysis Center After Review By A Qualified Individual. Devices May Allow Remote Access And Display Of Electrocardiograms Acquired. Not For Use For Detection Or Notification Of Hemodynamically Unstable Or Life-threatening Arrhythmias Or Cardiac Events Requiring Urgent Medical Response. Not Intended For Patients At Elevated Risk Of Serious Cardiovascular Events That Would Require Prompt Intervention. It Is Not Intended For Monitoring Patients During Cardiac Rehabilitation Outside Of Healthcare Facilities. Devices Are Intended For Prescription Use Only.