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Patient monitor module, multifunction

Australia TGA ARTG Registered Device · Symbiotic Devices Pty Ltd · WR Medical Electronics Co · Class IIa · Started August 31, 2023

Good Name: Symbiotic Devices Pty Ltd - Patient monitor module, multifunction

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
August 31, 2023
Effective Date
August 31, 2023
Sponsor
Manufacturer
Country
United States of America
Address
1700 Gervais Avenue MaplewoodMN 55109
Intended purpose

Intended to record and indicate the following parameters during autonomic testing manoeuvres: - Expiratory pressure recording and display - Respiratory effort - Breathing Cue metronome - Heart rate via electrocardiography (ECG) - Non-invasive blood pressure from optional external device The device does not make a diagnosis or indicate by itself that any disease state exists. The device is not designed for self-monitoring of patients.

About this record

Access comprehensive regulatory information for Patient monitor module, multifunction in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Symbiotic Devices Pty Ltd, manufactured by WR Medical Electronics Co in United States of America. The device registration started on August 31, 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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