Taiwan's first FDA/TFDA cleared EEG Amplifier

The 8-Channel EEG Amplifier developed by HippoScreen passed a series of tests, including safety, EMC, performance, software validation and usability test, and was certified to comply with IEC 60601-1 and IEC 60601-2-26 by SGS. It is FDA 510(k) cleared medical device (K number: K201747) and also received TFDA approval(衛部醫器製字第007081號).

EEG Amplifier specification

TFDA Medical Device Approval