The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smartep, Model M010000.
| Device ID | K070608 |
| 510k Number | K070608 |
| Device Name: | SMARTEP, MODEL M010000 |
| 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 | ETN |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020808 | K070608 | 000 |
| 00817020020457 | K070608 | 000 |
| 00817020020310 | K070608 | 000 |
| 00817020020303 | K070608 | 000 |
| 00817020020297 | K070608 | 000 |
| 00817020020068 | K070608 | 000 |