HolterCare

Primary DI

00856298006169

Brand

HolterCare

Company

SCOTTCARE CORPORATION, THE

Model

HolterCare

Catalog number

100087

Device description

The ScottCare HolterCare Analysis System is intended for general hospital or clinical use bymedical professionals whenever it is required to assess a patient’s long-term, continuous,ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memoryHolter recorder. This product allows a trained physician, or other health care professional, todownload and analyze the data from the recorder, review it, and produce printed reports. This willenable: The evaluation of arrhythmias and ischemic attacks. The reporting of PQRST intervals. Clinical and epidemiological research studies. The evaluation of a patient’s response after resuming occupational or recreational activities (e.g.,after M.I. or cardiac surgery). The evaluation of patients with Pacemakers.The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered inthe Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient.This device is available for sale to, or on the order of, a licensed physician only and is not intendedfor any home-use applications.

Published

2016-09-19

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information