Masimo Radical-7 Pulse CO-Oximeter - HSA Registration DE0506258
Access comprehensive regulatory information for Masimo Radical-7 Pulse CO-Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506258 and owned by Masimo Corporation. The device was registered on October 06, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. The Masimo Radical-7 Pulse CO-Oximeter may be provided with the oxygen reserve index (ORi) as an adjunct to standard pulse oximetry monitoring. ORi is a trend index that extends oxygen monitoring to patients on supplemental oxygen in adult and pediatric patients.