Screener Cart - Screener Cart with built-in Isolation Transformer (Solo/Aria)
2026-06-10
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1052723 | 1000113738 | INTELLIGENT HEARING SYSTEMS CORP. | 1 | N | 2026-01-01 | 6860 Sw 81st St MIAMI FL US 33143 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 42141 | 1234579140 | K964426 | SMARTOAE | EWO | 1997-02-03 |
| 42141 | 1285089180 | K925648 | SMART-SCREENER (AUDITORY) | GWJ | 1993-05-11 |
| 42141 | 1751829249 | K914876 | OPTI-AMP | GWL | 1992-01-10 |
| 42141 | 1337207245 | K904926 | SMART-EP | GWJ | 1991-08-02 |
| 42141 | 1614992525 | K900096 | INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) | EWO | 1990-05-31 |
| 42141 | 1023416726 | K163326 | SmartEP | GWJ | 2017-09-29 |
| 42141 | 1863082053 | K090579 | SMARTSCREENER-PLUS2 | GWJ | 2009-07-07 |
| 42141 | 1471649698 | K073384 | SMART COUPLER, MODEL M015401 | GWJ | 2008-02-28 |
| 42141 | 1186861498 | K070608 | SMARTEP, MODEL M010000 | GWJ | 2007-07-18 |
| 42141 | 1866940895 | K063402 | WICK ELECTRODE, MODEL M019260 | GXY | 2006-12-11 |
| 42141 | 1119348167 | K061443 | SMART USBLITE, MODEL M011120 | GWJ | 2006-06-23 |
| 42141 | 1406500794 | K052060 | OPTI-AMP DC-POWERED | GWL | 2005-08-31 |
| 42141 | 1279579564 | K031051 | SMARTEP-ASSR, MODEL M811007 | GWJ | 2004-02-20 |
| 42141 | 1586010425 | K023859 | SMARTTROAE | EWO | 2003-01-08 |
| 42141 | 1297714990 | ||||
| 42141 | 1324376661 | ||||
| 42141 | 1778346334 | ||||
| 42141 | 2044739152 |
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