# K192889: Neo

- Pathway: 510(k) (Traditional)
- Applicant: Eemagine Medical Imaging Solutions GmbH
- Decided: Jan 30, 2020 after 112 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: 1 generation back to K093949 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093949: Olympic Brainz Monitor Model OBM70001, Natus Medical, Inc. (2010) Summary page 5.

## Indications for use
The nëo monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to the user.

Source page: https://510kreport.com/device/K192889
Methodology: https://510kreport.com/methodology