BRM3 Brain Monitor
by Brainz Instruments, Ltd. 510(k)
Active
510(k) K071449
Overview
The BRM3 Brain Monitor is an Amplitude-Integrated Electroencephalograph (aEEG), a Class 2 medical device used to measure and record the electrical activity of the brain. It employs multiple electrodes placed on the scalp to capture and process continuous EEG signals, enabling real-time monitoring of cerebral function. This device is designed for clinical use in neurology to assess brain activity patterns, particularly in critical care settings such as neonatal and adult intensive care units. Its output provides a visual representation of brain activity, aiding in the diagnosis and management of neurological conditions.
The BRM3 Brain Monitor is supplied as a reusable medical device intended for use in clinical environments. It is not classified as sterile and requires proper cleaning and maintenance between uses to ensure accuracy and safety. The device adheres to FDA regulatory standards under 21 CFR §882.1400 and holds a 510(k) clearance (K071449) through the Traditional 510(k) pathway, with a product code of OMA. It is intended for use in neurology and is optimized for settings requiring continuous brain activity monitoring, such as intensive care units.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071449 | Date14 Sep 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OMA
- FDA applicant
- Brainz Instruments , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Brainz Instruments, Ltd.
Questions
What is the BRM3 Brain Monitor used for?
The BRM3 Brain Monitor is an amplitude-integrated electroencephalograph (aEEG) designed to measure and continuously record the electrical activity of the brain. It is primarily used in clinical settings, such as neonatal and adult intensive care units, to assess brain function patterns. The device provides a visual representation of brain activity, helping clinicians diagnose and manage neurological conditions by monitoring cerebral function in real time.
Is the BRM3 Brain Monitor sterile?
No, the BRM3 Brain Monitor is not classified as a sterile device. It is intended for reusable clinical use and requires proper cleaning and maintenance between uses to ensure accuracy, safety, and compliance with regulatory standards.
How is the BRM3 Brain Monitor supplied?
The BRM3 Brain Monitor is supplied as a reusable medical device. It is not intended for single-use applications and must be cleaned and maintained according to manufacturer guidelines to preserve its functionality and ensure reliable performance in continuous brain activity monitoring.
What regulatory pathway does the BRM3 Brain Monitor follow?
The BRM3 Brain Monitor holds FDA clearance under the Traditional 510(k) pathway, with a clearance number of K071449. It is classified under product code OMA and adheres to regulatory standards outlined in 21 CFR §882.1400. The device was reviewed by the Neurology Advisory Committee and is intended for use in neurology.
What types of clinical environments is the BRM3 Brain Monitor optimized for?
The BRM3 Brain Monitor is optimized for use in critical care settings where continuous brain activity monitoring is essential. This includes neonatal intensive care units (NICUs) and adult intensive care units (ICUs), where clinicians rely on real-time EEG data to assess and manage neurological conditions effectively.