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FDA 510(k) Application Details - K163326
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K163326
Device Name
Stimulator, Auditory, Evoked Response
Applicant
INTELLIGENT HEARING SYSTEMS
6860 SW 81ST st Street
MIAMI, FL 33143 US
Other 510(k) Applications for this Company
Contact
Edward Miskiel
Other 510(k) Applications for this Contact
Regulation Number
882.1900
More FDA Info for this Regulation Number
Classification Product Code
GWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/28/2016
Decision Date
09/29/2017
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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