The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smart Usblite, Model M011120.
| Device ID | K061443 |
| 510k Number | K061443 |
| Device Name: | SMART USBLITE, MODEL M011120 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | INTELLIGENT HEARING SYSTEMS 6860 S.W. 81ST ST. Miami, FL 33143 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 6860 S.W. 81ST ST. Miami, FL 33143 |
| Product Code | GWJ |
| Subsequent Product Code | EWO |
| Subsequent Product Code | GWL |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2006-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020029931 | K061443 | 000 |
| 00817020029924 | K061443 | 000 |
| 00817020029917 | K061443 | 000 |
| 00817020029900 | K061443 | 000 |
| 00817020020136 | K061443 | 000 |
| 00817020020129 | K061443 | 000 |