8-CH Electroencephalography Amplifier

Amplifier, Physiological Signal

HippoScreen Neurotech Corp.

The following data is part of a premarket notification filed by Hipposcreen Neurotech Corp. with the FDA for 8-ch Electroencephalography Amplifier.

Pre-market Notification Details

Device IDK201747
510k NumberK201747
Device Name:8-CH Electroencephalography Amplifier
ClassificationAmplifier, Physiological Signal
Applicant HippoScreen Neurotech Corp. 2F., No. 578, Ruiguang Rd., Neihu District Taipei City,  TW 11492
ContactWilliam Lan
CorrespondentWilliam Lan
HippoScreen Neurotech Corp. 2F., No. 578, Ruiguang Rd., Neihu District Taipei City,  TW 11492
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-26
Decision Date2020-12-27

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