Pure Global

Patient monitor module, oximeter, pulse

Access comprehensive regulatory information for Patient monitor module, oximeter, pulse in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Philips Electronics Australia Ltd, manufactured by Respironics Inc in United States of America. The device registration started on May 30, 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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TGA ARTG Official Data
Class IIb
Class IIb
Patient monitor module, oximeter, pulse
Australia TGA ARTG Registered Device
Good Name: Philips Electronics Australia Ltd - Patient monitor module, oximeter, pulse
Pure Global
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Intended Purpose

Intended to be combined with a Nonin PureLight pulse oximeter and ventilator to form an oximetry system. This system measures and displays functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult, pediatric, and infant patients.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 30, 2023
Effective Date
May 30, 2023
Manufacturer
Country
United States of America
Address
1001 Murry Ridge Lane, Murrysville, PA, 15668-8550