Cleared Traditional

Zio AT ECG Monitoring System

K163512 · iRhythm Technologies, Inc. · Cardiovascular

Jun 2017

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K163512 is an FDA 510(k) clearance for the Zio AT ECG Monitoring System, a Outpatient Cardiac Telemetry (Class II — Special Controls, product code QYX), submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 2, 2017, 169 days after receiving the submission on December 15, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K163512 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2016
Decision Date	June 02, 2017
Days to Decision	169 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.