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Intelligent Hearing Systems

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K163326 SmartEPGWJ2017-09-29 View
510(k) K090579 SMARTSCREENER-PLUS2GWJ2009-07-07 View
510(k) K073384 SMART COUPLER, MODEL M015401GWJ2008-02-28 View
510(k) K070608 SMARTEP, MODEL M010000GWJ2007-07-18 View
510(k) K063402 WICK ELECTRODE, MODEL M019260GXY2006-12-11 View
510(k) K061443 SMART USBLITE, MODEL M011120GWJ2006-06-23 View
510(k) K052060 OPTI-AMP DC-POWEREDGWL2005-08-31 View
510(k) K031051 SMARTEP-ASSR, MODEL M811007GWJ2004-02-20 View
510(k) K023859 SMARTTROAEEWO2003-01-08 View
510(k) K964426 SMARTOAEEWO1997-02-03 View
510(k) K925648 SMART-SCREENER (AUDITORY)GWJ1993-05-11 View
510(k) K914876 OPTI-AMPGWL1992-01-10 View
510(k) K904926 SMART-EPGWJ1991-08-02 View
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