Atlas FDA

Intelligent Hearing Systems

13 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SmartEP (K163326)Intelligent Hearing Systems2017-09-29
SMARTSCREENER-PLUS2 (K090579)Intelligent Hearing Systems2009-07-07
SMART COUPLER, MODEL M015401 (K073384)Intelligent Hearing Systems2008-02-28
SMARTEP, MODEL M010000 (K070608)Intelligent Hearing Systems2007-07-18
WICK ELECTRODE, MODEL M019260 (K063402)Intelligent Hearing Systems2006-12-11
SMART USBLITE, MODEL M011120 (K061443)Intelligent Hearing Systems2006-06-23
OPTI-AMP DC-POWERED (K052060)Intelligent Hearing Systems2005-08-31
SMARTEP-ASSR, MODEL M811007 (K031051)Intelligent Hearing Systems2004-02-20
SMARTTROAE (K023859)Intelligent Hearing Systems2003-01-08
SMARTOAE (K964426)Intelligent Hearing Systems1997-02-03
SMART-SCREENER (AUDITORY) (K925648)Intelligent Hearing Systems1993-05-11
OPTI-AMP (K914876)Intelligent Hearing Systems1992-01-10
SMART-EP (K904926)Intelligent Hearing Systems1991-08-02

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Every clearance here is in the API, with alerts when new ones post.