Modification to Bio-Logic Sleepscan

K983913 is the FDA 510(k) clearance record for MODIFICATION TO BIO-LOGIC SLEEPSCAN, a class II device, cleared for Bio-Logic Systems Corp. on 1998-11-25 under FDA product code OLV (Standard Polysomnograph With Electroencephalograph). FDA's definition for product code OLV reads: "Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review...". FDA records list 57 510(k) clearances for Bio-Logic Systems Corp., from 1981-02-05 to 2012-11-01. As of 2026-09-10, FDA records show no recalls naming K983913.