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FDA 510(k) Application Details - K151616
Device Classification Name
Tester, Auditory Impedance
More FDA Info for this Device
510(K) Number
K151616
Device Name
Tester, Auditory Impedance
Applicant
INTERACOUSTICS A/S
DREJERVAENGET 8
ASSENS DK-5610 DK
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Contact
ERIK NIELSEN
Other 510(k) Applications for this Contact
Regulation Number
874.1090
More FDA Info for this Regulation Number
Classification Product Code
ETY
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More FDA Info for this Product Code
Date Received
06/15/2015
Decision Date
07/15/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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