Ambulatory Eeg/sleep Recorder and Accessories, Model # Ssr3201

K983072 is the FDA 510(k) clearance record for AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201, a class II device, cleared for Nihon Kohden America, Inc. on 1998-12-01 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 166 510(k) clearances for Nihon Kohden America, Inc., from 1979-09-04 to 2012-03-22. As of 2026-09-10, FDA records show no recalls naming K983072.