# K093949: Olympic Brainz Monitor Model OBM70001

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Jun 16, 2010 after 175 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192889: Neo (2020), 0 descendants of its own
- K123079: Olympic Brainz Monitor (2013), 0 descendants of its own

## Indications for use
The Olympic Brainz Monitor (OR3M) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. • The signals acquired from P3-P4, 03-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a post-conceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain. • The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity of Hypoxic-lschemnic Encephalopathy and long-term outcome in full term neonates (post-conceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event. The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.

Source page: https://510kreport.com/device/K093949
Methodology: https://510kreport.com/methodology