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510(k) K070608

SMARTEP, MODEL M010000 by Intelligent Hearing Systems — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2007
Date Received
March 5, 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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  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)