# K983913: Modification to Bio-Logic Sleepscan

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Nov 25, 1998 after 21 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: 1 generation back to K894155 (1990). 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)
- K894155: Sleepscan, Biologic Systems Corp. (1990) Summary page 1.

## Indications for use
The Bio-logic Sleepscan product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. Sleepscan Analysis performs calculations and presents recorded data in various ways on the computer screen and in reports. The Analysis features in the Sleepscan product are intended to be performed without patient hookup being necessary, and may even be performed on a different computer system from that which was used for the patient recording. It can be used for patients of all ages, from childrea to adults, including geriatric patients. The use of the Sleepscan family of products is to be performed under the prescription and supervision of a physician or other trained health care professional. The primary feature modification represented in this Special 510(k) is for the use of the Microsoft Windows operating system and its associated user interface functionality.

Source page: https://510kreport.com/device/K983913
Methodology: https://510kreport.com/methodology