The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smart-ep.
| Device ID | K904926 |
| 510k Number | K904926 |
| Device Name: | SMART-EP |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | INTELLIGENT HEARING SYSTEMS 1125 N.E. 125 STREET, SUITE 206 North Miami, FL 33161 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 1125 N.E. 125 STREET, SUITE 206 North Miami, FL 33161 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-31 |
| Decision Date | 1991-08-02 |