Cleared Abbreviated

MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System

K160064 · Infobionic, Inc. · Cardiovascular

Mar 2016

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K160064 is an FDA 510(k) clearance for the MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, a Outpatient Cardiac Telemetry (Class II — Special Controls, product code QYX), submitted by Infobionic, Inc. (Lowell, US). The FDA issued a Cleared decision on March 11, 2016, 58 days after receiving the submission on January 13, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K160064 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2016
Decision Date	March 11, 2016
Days to Decision	58 days
Submission Type	Abbreviated
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.