# K071449: BRM3 Brain Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Brainz Instruments, Ltd.
- Decided: Sep 14, 2007 after 113 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K963644 (1996). 14 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030489: BRM2 Brain Monitor, Brainz Instruments, Ltd. (2003) Summary page 1.
- K033010: BRM2 Brain Monitor, Brainz Instruments, Ltd. (2003) Summary page 1.
- K983229: Olympic Medical Lectromed Cerebral Function Monitor System, Olympic Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K082886: Zoom-100DC (2009), 11 descendants of its own
- K081551: Twin Neurotrac-Iii (2008), 8 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (2010), 6 descendants of its own
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own

## Indications for use
The Brainz Instruments Lid BRM3 Brain Monitor is an electroencephalograph or EEG system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient’s brain obtained by placing two or more electredes on the head. . The BRM3 Brain Monitor is intended for use lo monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for clinical research. . The BRM3 Brain Monitor is intended for use only with neonalal patients, defined as from birth o 28 days post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks. « The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient’s condition.

Source page: https://510kreport.com/device/K071449
Methodology: https://510kreport.com/methodology