Pulse Co-oximeter
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
16-11-2017
अनुरोध भेजा।
थमां उपलब्ध:
Masimo Australia Pty Ltd
वर्ग:
Class IIb
द्वारा बनाया गया:
Masimo Corporation 52 Discovery, Irvine, CA, 92618 United States Of America
चिकित्सीय क्षेत्र:
46201 - Pulse Co-oximeter
चिकित्सीय संकेत:
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.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2008-12-03
