Intelligent Hearing Systems
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K925648 | SMART-SCREENER (AUDITORY) | May 11, 1993 |
| K914876 | OPTI-AMP | January 10, 1992 |
| K904926 | SMART-EP | August 2, 1991 |