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Patient monitor module, electrocardiograph - ARTG 421957

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.

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Class IIb
ARTG 421957
Class IIb
Patient monitor module, electrocardiograph
ARTG ID: 421957
Good Name: Welch Allyn Australia Pty Limited - Patient monitor module, electrocardiograph
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
421957
Start Date
September 18, 2023
Effective Date
September 18, 2023
Manufacturer
Country
United States of America
Address
7010 Fly Road Suite 5, East Syracuse, New York, 13057