# K193159: NeuroAmp II, NeuroAmp II.5s

- Pathway: 510(k) (Traditional)
- Applicant: Corscience GmbH & Co. KG
- Decided: Dec 30, 2020 after 411 days
- Product code: GWQ (Full-Montage Standard 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 K920038 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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 5.
- K180290: Natus Brain Monitor Amplifier, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (2018) Summary page 5.
- K073557: Eeg Neuroamp, Model CS10137, Corscience GmbH & Co. KG (2008) Summary page 5.

## Indications for use
The EEG NeuroAmp I1.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories. The EEG NeuroAmp I1.5s can also be used for biofeedback and relaxation purposes. For purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp I1.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use. The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K193159
Methodology: https://510kreport.com/methodology