Singapore HSA registration DE0504087
Advanced Brain Monitoring Sleep Profiler System
Singapore·CLASS B·Advanced Brain Monitoring, Inc.·Registered February 05, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0504087
- Registration Date
- February 05, 2020
- Change Notification Approval Date
- July 29, 2020
- Retention Due Date
- February 04, 2026
Product description
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.
Product Owner
- Short Name
- Advanced Brain Monitoring, Inc.
- Address
- 2237 Faraday Avenue, Suite 100, Carlsbad, CA 92008, UNITED STATES
Registrant
- Address
- 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Importer
- Address
- 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model information
- Model Name(s)
- Sleep Profiler PSG2 LE Device Kit (ezRIP) Sleep Profiler PM3 LE Device kit Airflow Adapter Kit Sleep Profiler PSG2 LE Device Kit (Piezo) Sleep Profiler PSG2/PM3 50-Night Study Kit Adult Nasal High Performance Sensor Cannula Sleep Profiler LE Device Kit Sleep Profiler Headband Kit Sleep Profiler Strip Kit Sleep Profiler 50-Night Study Kit Adult General Purpose Electrodes Effort Cable Kit Dual Lead Cable 20" Kit External Battery Kit External Battery Cable Kit
- Model Identifier(s)
- SP29-1001.LE SP29-1002.LE SP29-1004 SP29-1006.LE SP29-4305 SP29-4401 SP40-1001.LE SP40-4101 SP40-4225.1 SP40-4305 SP40-4305.50 UN03-4003 UN03-4004 UN03-5203 UN03-5204
About this record
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.
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