Information system software, application program, cardiology

Available from:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Class:

Class IIa

Manufactured by:

Lumedx Corporation 555 Twelfth Street Suite 2060, Oakland, CA, 94607 United States Of America

Therapeutic area:

44098 - Information system software, application program, cardiology

Therapeutic indications:

The product is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, or Holter) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

Authorization status:

A

Authorization date:

2013-11-30