# K974583: Deeglite

- Pathway: 510(k) (Traditional)
- Applicant: Grass-Telefactor Product Group
- Decided: Jun 9, 1998 after 203 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
Longest line of descent: 2 generations back to K884937 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972202: Deeg-Lite, Grass-Telefactor Product Group (1997) Summary page 1.

## Indications for use
The DEEG-LITE-OXY is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).

Source page: https://510kreport.com/device/K974583
Methodology: https://510kreport.com/methodology