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FDA 510(k) Application Details - K122067
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K122067
Device Name
Stimulator, Auditory, Evoked Response
Applicant
GN OTOMETRICS
HOERSKAETTEN 9
TAATRUP DK-2630 DK
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Contact
TOM RINIKER
Other 510(k) Applications for this Contact
Regulation Number
882.1900
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Classification Product Code
GWJ
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More FDA Info for this Product Code
Date Received
07/16/2012
Decision Date
09/27/2012
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
Y
Expedited Review
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