# K960170: Electroencephalograph (Eeg)

- Pathway: 510(k) (Traditional)
- Applicant: Moberg Medical, Inc.
- Decided: Mar 1, 1996 after 45 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851300 (1985). 2 ancestors in all.
16 later devices descend from it; 2 cite 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)
- K914571: Neurotrac II, Moberg Medical, Inc. (1992) Summary page 2.
- K851300: Neuropack 8, Mee-4108, Nihon Kohden America, Inc. (1985) Summary page 1.
- (no number) Viking IV: named in the summary without a submission number
- (no number) Excel: named in the summary without a submission number

## Most influential descendants
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K081551: Twin Neurotrac-Iii (2008), 8 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K173366: NicoletOne (2018), 3 descendants of its own

## Indications for use
To record the electroencephalogram (EEG) and evoked potentials (EP’s) over extended periods of time such as during surgery and intensive care stays in order for trained health care professionals to observe changes.

Source page: https://510kreport.com/device/K960170
Methodology: https://510kreport.com/methodology