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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K201747
Device Name 8-CH Electroencephalography Amplifier
Applicant
Hipposcreen Neurotech Corp.
2f., # 578, Ruiguang Rd., Neihu District
Taipei City,  TW 11492
Applicant Contact William Lan
Correspondent
Hipposcreen Neurotech Corp.
2f., # 578, Ruiguang Rd., Neihu District
Taipei City,  TW 11492
Correspondent Contact William Lan
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
OMC  
Date Received06/26/2020
Decision Date 12/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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