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Pneumotachograph

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Pneumotachograph
Australia TGA ARTG Registered Device
Good Name: Innervate Pty Ltd - Pneumotachograph
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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. PNTโ€™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 PNTโ€™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.

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
Manufacturer
Country
United States of America
Address
8325 Cole Parkway, Shawnee, KS, 66227