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510(k) K073384

SMART COUPLER, MODEL M015401 by Intelligent Hearing Systems — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2008
Date Received
December 3, 2007
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

Other clearances by Intelligent Hearing Systems

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  • K063402 — WICK ELECTRODE, MODEL M019260 (December 11, 2006)
  • K061443 — SMART USBLITE, MODEL M011120 (June 23, 2006)
  • K052060 — OPTI-AMP DC-POWERED (August 31, 2005)
  • K031051 — SMARTEP-ASSR, MODEL M811007 (February 20, 2004)
  • K023859 — SMARTTROAE (January 8, 2003)
  • K964426 — SMARTOAE (February 3, 1997)
  • K925648 — SMART-SCREENER (AUDITORY) (May 11, 1993)

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