Pulse oximeter probe/processor
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
18-10-2022
अनुरोध भेजा।
थमां उपलब्ध:
GE Healthcare Australia Pty Ltd
वर्ग:
Class IIb
द्वारा बनाया गया:
GE Healthcare Finland Oy Kuortaneenkatu 2, Helsinki, FI-00510 Finland
चिकित्सीय क्षेत्र:
65829 - Pulse oximeter probe/processor
चिकित्सीय संकेत:
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR) parameter. The Portrait Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2022-09-21
