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510(k) K103760

TITAN by Interacoustics A/S — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2011
Date Received
December 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

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  • K151616 — AT235 (July 15, 2015)
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  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
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