# K170441: ElectroTek

- Pathway: 510(k) (Traditional)
- Applicant: Mobilemedtek
- Decided: Jun 5, 2017 after 111 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001564 (2000). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143233: Mitsar-EEG, Mitsar Co., Ltd. (2015) Summary page 4.
- K103140: Nicolet Wireless Eeg, Carefusion 209, Inc. (2011) Summary page 4.
- K011204: Neurofax, Models Eeg-1100A, Eeg-9100A, Nihon Kohden America, Inc. (2001) Summary page 4.

## Most influential descendants
- K212788: Seer Home (2022), 0 descendants of its own

## Recalls of this device
- Oct 11, 2019 · Class II · Z-0722-2020: Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.
- Oct 11, 2019 · Class II · Z-0723-2020: Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.

## Indications for use
The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing electrodes on the patient scalp. The ElectroTek is intended to be used for such studies as electroencephelogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

Source page: https://510kreport.com/device/K170441
Methodology: https://510kreport.com/methodology