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510(k) K121847

TITAN by Interacoustics A/S — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2012
Date Received
June 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

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