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Patient monitor, electrocardiograph - ARTG 236084

Access comprehensive regulatory information for Patient monitor, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 236084 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by IVY Biomedical Systems Inc in United States of America. The device registration started on April 11, 2015.

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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TGA ARTG Official Data
Class IIb
ARTG 236084
Class IIb
Patient monitor, electrocardiograph
ARTG ID: 236084
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Patient monitor, electrocardiograph
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Intended Purpose

The Ivy Biomedical Model 7000 Series Cardiac Trigger Monitors are simple-to-use instruments for monitoring ECG and Heart Rate. They are designed for use in the ICU, CCU and operating room conditions. They can sound an alarm when HR falls outside of preset limits. They provide an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
236084
Start Date
April 11, 2015
Effective Date
April 11, 2015
Manufacturer
Country
United States of America
Address
11 Business Park Drive, BRANFORD, Connecticut, 06405