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Sensor, oxygen - ARTG 321729

Access comprehensive regulatory information for Sensor, oxygen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 321729 and sponsored by Swirl Technologies Pty Ltd T/A Parker Healthcare, manufactured by Maxtec Inc in United States of America. The device registration started on August 13, 2019.

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 IIa
ARTG 321729
Class IIa
Sensor, oxygen
ARTG ID: 321729
Good Name: Swirl Technologies Pty Ltd T/A Parker Healthcare - Sensor, oxygen
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Intended Purpose

Oxygen sensors are not stand alone medical devices and must be used as a component in an anesthesia machine, ventilator or oxygen monitor / analyzer device that can interpret the output voltage of the sensor into usable data that can be read by clinician.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
321729
Start Date
August 13, 2019
Effective Date
August 13, 2019
Manufacturer
Country
United States of America
Address
2305 South 1070 West , Salt Lake City, UT, 84119