Pulse Co-oximeter

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
16-11-2017

可用日期:

Masimo Australia Pty Ltd

类:

Class IIb

厂商:

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

治疗领域:

46201 - Pulse Co-oximeter

疗效迹象:

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.

授权状态:

A

授权日期:

2008-12-03

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