# K994142: Grass TS3201/6401 Eeg Amplifier System

- Pathway: 510(k) (Traditional)
- Applicant: Grass Instrument Co.
- Decided: Mar 6, 2000 after 89 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: 4 generations back to K884937 (1989). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973883: Bio-Logic Ceegraph 128-Channel Recording System, Bio-Logic Systems Corp. (1998) Summary page 1.
- K992291: H20- Tethered Option, Grass-Telefactor Product Group (1999) Summary page 1.

## Most influential descendants
- K050425: Aura-PSG (2005), 5 descendants of its own
- K071782: Micromed Brain Spy Plus, Embia Titanium Devices (2008), 4 descendants of its own
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 descendants of its own
- K133995: Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software (2015), 1 descendant of its own
- K220254: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (2022), 0 descendants of its own

## Indications for use
The TS3201/6401 amplifier system is designed for use in the recording of routine EEG, long-term EEG with patient video and overnight sleep/EEG recording applications (Polysomnography). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

Source page: https://510kreport.com/device/K994142
Methodology: https://510kreport.com/methodology