Advanced Brain Monitoring Sleep Profiler System - HSA Registration DE0504087
Access comprehensive regulatory information for Advanced Brain Monitoring Sleep Profiler System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504087 and owned by Advanced Brain Monitoring, Inc.. The device was registered on February 05, 2020.
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 X8 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit, and display physiological signals from adult patients. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 system only acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.