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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
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