Company ยท US
Intelligent Hearing Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2017. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2017 | K163326 | SmartEP Intelligent Hearing Systems | GWJ |
| Jul 7, 2009 | K090579 | SMARTSCREENER-PLUS2 Intelligent Hearing Systems | GWJ |
| Feb 28, 2008 | K073384 | SMART COUPLER, MODEL M015401 Intelligent Hearing Systems | GWJ |
| Jul 18, 2007 | K070608 | SMARTEP, MODEL M010000 Intelligent Hearing Systems | GWJ |
| Dec 11, 2006 | K063402 | WICK ELECTRODE, MODEL M019260 Intelligent Hearing Systems | GXY |
| Jun 23, 2006 | K061443 | SMART USBLITE, MODEL M011120 Intelligent Hearing Systems | GWJ |
| Aug 31, 2005 | K052060 | OPTI-AMP DC-POWERED Intelligent Hearing Systems | GWL |
| Feb 20, 2004 | K031051 | SMARTEP-ASSR, MODEL M811007 Intelligent Hearing Systems | GWJ |
| Jan 8, 2003 | K023859 | SMARTTROAE Intelligent Hearing Systems | EWO |
| Feb 3, 1997 | K964426 | SMARTOAE Intelligent Hearing Systems | EWO |
| May 11, 1993 | K925648 | SMART-SCREENER (AUDITORY) Intelligent Hearing Systems | GWJ |
| Jan 10, 1992 | K914876 | OPTI-AMP Intelligent Hearing Systems | GWL |
| Aug 2, 1991 | K904926 | SMART-EP Intelligent Hearing Systems | GWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2010 | Intelligent Hearing Systems Corp. Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016 Terminated |
GWJ | None listed |