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510(k) K904926

SMART-EP by Intelligent Hearing Systems — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
October 31, 1990
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

  • K163326 — SmartEP (September 29, 2017)
  • K090579 — SMARTSCREENER-PLUS2 (July 7, 2009)
  • K073384 — SMART COUPLER, MODEL M015401 (February 28, 2008)
  • K070608 — SMARTEP, MODEL M010000 (July 18, 2007)
  • 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)

Other clearances for product code GWJ

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  • K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) (March 8, 2024)
  • K220139 — QScreen (August 3, 2022)
  • K211147 — ALGO 7i (October 14, 2021)
  • K193033 — GSI Audera Pro (April 24, 2020)
  • K163326 — SmartEP (September 29, 2017)
  • 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)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)