# K970951: Grass Brainwave Software

- Pathway: 510(k) (Traditional)
- Applicant: Astro-Med, Inc.
- Decided: May 19, 1997 after 66 days
- Product code: OLV (Standard Polysomnograph With 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stellate Systems Eclipse software: named in the summary without a submission number
- (no number) Melville Diagnostics Sandman software systems: named in the summary without a submission number

## Most influential descendants
- K980477: Image Vue Eeg (1998), 0 descendants of its own

## Indications for use
Grass Brainwave Software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG/PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. Its specifications and features make it especially well suited to electroencephalography and polygraphic sleep recordings.

Source page: https://510kreport.com/device/K970951
Methodology: https://510kreport.com/methodology