Australia TGA ARTG record

Pneumotachograph

Australia TGA ARTG Registered Device · Innervate Pty Ltd · Hans Rudolph Inc · Class IIa · Started December 17, 2021

Good Name: Innervate Pty Ltd - Pneumotachograph

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 17, 2021
Effective Date: December 17, 2021

Sponsor

Name: Innervate Pty Ltd

Manufacturer

Name: Hans Rudolph Inc
Country: United States of America
Address: 8325 Cole Parkway, Shawnee, KS, 66227

Intended purpose

Pneumotachometers (PNT) are designed for use as a component of a respiratory flow measurement system. The PNT converts the flow of air into a proportional linear differential pressure signal for input into a differential gas pressure sensor. The output from the pressure sensor is used for flow and volume measurements. The end user is required to assemble the additional instrumentation required to integrate the PNT into the flow system. PNT’s are available in a wide range of sizes as specified by the physical size, port diameter connections, flow range and dead space volume. Heated PNT’s are recommended when used in a humidified air flow circuit to eliminate moisture build up on the screens which can affect the flow measurement process.

About this record

Access comprehensive regulatory information for Pneumotachograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Innervate Pty Ltd, manufactured by Hans Rudolph Inc in United States of America. The device registration started on December 17, 2021.

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.