Pulse Co-oximeter

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Masimo Australia Pty Ltd

Class:

Class IIb

Manufactured by:

Masimo Corporation 52 Discovery, Irvine, CA, 92618 United States Of America

Therapeutic area:

46201 - Pulse Co-oximeter

Therapeutic indications:

The device is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation, methemoglobin saturation, total haemoglobin concentration, and/or respiratory rate.; and is indicated for use with adult, paediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments. The device has an additional mode to provide clinicians with a guided tool to help screen newborns for Critical Congenital Heart Disease (CCHD) per the established CCHD Screening protocol.

Authorization status:

A

Authorization date:

2008-12-03