ZIO SR ECG Monitoring Service

K143513DSH6/19/2015

Applicant

iRhythm Technologies, Inc.

Intended Use

The ZIO® SR ECG Monitoring Service is intended to capture, analyze, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days).

Indications for Use

The ZIO® SR ECG Monitoring Service is intended to capture, analyze, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

Predicate Devices

  • K142681 - ZEUS (ZIO ECG Utilization Services) System (DSH)
  • K121319 - ZIO PATCH (DSH)
  • K121628 - EPI MINI (DSH)