GE CARESCAPE Monitor B850 - HSA Registration DE0005941
Access comprehensive regulatory information for GE CARESCAPE Monitor B850 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005941 and owned by GE Healthcare Finland Oy. The device was registered on January 14, 2011.
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.
Intended for use on adult, pediatric & neonatal patients. One patient at a time. For monitoring of: • hemodynamic (incl. ECG, ST segment, arrhythmia detection, ECG diagnostic analysis & measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution & pulse contour), temperature, mixed venous oxygen saturation, central venous oxygen saturation, & Surgical Pleth Index), • respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), • neurophysiological status (incl. electroencephalography, Entropy, Bispectral Index, and neuromuscular transmission). Intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.