# K960273: Harmonie Sensa

- Pathway: 510(k) (Traditional)
- Applicant: Stellate Systems
- Decided: Apr 4, 1996 after 76 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems’ RHYTHM and MONITOR software. The software remains consistent with its original design objectives: to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology. to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards. to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities. to complement the conventional continuous EEG recording, not replace it. The software does not make any judgment of normality or abnormality of the displayed EEG or the results of an analysis. It is not intended for extended EEG monitoring used in critical care or intra-operative settings. In no way is the software or its function represented as being in and of itself diagnostic.

Source page: https://510kreport.com/device/K960273
Methodology: https://510kreport.com/methodology