Pulse Co-oximeter probe, single-use
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
16-11-2017
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Available from:
Masimo Australia Pty Ltd
Class:
Class IIb
Manufactured by:
Masimo Corporation 52 Discovery, Irvine, CA, 92618 United States Of America
Therapeutic area:
47581 - Pulse Co-oximeter probe, single-use
Therapeutic indications:
A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as arterial oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection.The device is single use.
Authorization status:
A
Authorization date:
2008-12-03
