Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132957
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K132957
Device Name
Stimulator, Auditory, Evoked Response
Applicant
GN OTOMETRICS
8870 RAVELLO CT
NAPLES, FL 34114 US
Other 510(k) Applications for this Company
Contact
DANIEL KAMM, P.E.
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
09/20/2013
Decision Date
02/27/2014
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact