ARTG 421957Patient monitor module, electrocardiograph
ARTG ID: 421957 · 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
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 421957
- Start Date
- September 18, 2023
- Effective Date
- September 18, 2023
- Country
- United States of America
- Address
- 7010 Fly Road Suite 5, East Syracuse, New York, 13057
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.
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 registered under ARTG number 421957 and 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.