FDA 510(k) Application Details - K201747

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K201747
Device Name	Amplifier, Physiological Signal
Applicant	HippoScreen Neurotech Corp. 2F., No. 578, Ruiguang Rd., Neihu District Taipei City 11492 TW Other 510(k) Applications for this Company
Contact	William Lan Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2020
Decision Date	12/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review