Australia TGA ARTG record

Patient monitor module, electrocardiograph

Australia TGA ARTG Registered Device · Welch Allyn Australia Pty Limited · Global Instrumentation LLC · Class IIb · Started September 18, 2023

Good Name: Welch Allyn Australia Pty Limited - Patient monitor module, electrocardiograph

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: September 18, 2023
Effective Date: September 18, 2023

Sponsor

Name: Welch Allyn Australia Pty Limited

Manufacturer

Name: Global Instrumentation LLC
Country: United States of America
Address: 7010 Fly Road Suite 5, East Syracuse, New York, 13057

Intended purpose

The ECG/impedance Respiration module is intended for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia, and ventricular fibrillation in general medical and surgical floors, general hospital and alternate professional healthcare environments. The system is indicated for use in pediatric and adult patients.

About this record

Access comprehensive regulatory information for Patient monitor module, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Welch Allyn Australia Pty Limited, manufactured by Global Instrumentation LLC in United States of America. The device registration started on September 18, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.