Pulse Co-oximeter

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
16-11-2017

MAH:

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_indication:

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