# K983072: Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Dec 1, 1998 after 90 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 K930790 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962103: Bio-Logic Sleepscan Product with Built-in Oximeter, Bio-Logic Systems Corp. (1996) Summary page 1.
- K961642: Medilog MR95, Oxford Instruments, Plc. (1997) Summary page 1.

## Indications for use
The SSR3201 Ambulatory EEG/Sleep Recorder is Intended for medical purpeses to record electrical activity of the brain (EEG) and to record physlological data required for sleep studies (Polysomnography or PSG). These studies Including EEG, eye movement (EQG), resplratory signals such as air flow or air pressure and thoraco-abdominal movement, chin and arm/leg movement (EMG), body position, EKG and blood oxygen saturation. The device does not provide alarms and can not be used as an automated apnea monitor. This device Is intended to record up to 24 hours of continuous patient data for freely-moving or sleeping patients both inside and outside of a medical facility. The SSR3201 is Intended to record patient data for later review by a medical professional using a legally marketed digital EEG/PSG system to assist in diagnosing EEG related conditions such as epilepsy and sleep related breathing disorders.

Source page: https://510kreport.com/device/K983072
Methodology: https://510kreport.com/methodology