Australia TGA ARTG record

Patient monitor module, oximeter, pulse

Australia TGA ARTG Registered Device · Philips Electronics Australia Ltd · Respironics Inc · Class IIb · Started May 30, 2023

Good Name: Philips Electronics Australia Ltd - Patient monitor module, oximeter, pulse

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

Sponsor

Name: Philips Electronics Australia Ltd

Manufacturer

Name: Respironics Inc
Country: United States of America
Address: 1001 Murry Ridge Lane, Murrysville, PA, 15668-8550

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.

About this record

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.