The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smartep.
| Device ID | K163326 |
| 510k Number | K163326 |
| Device Name: | SmartEP |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | INTELLIGENT HEARING SYSTEMS 6860 SW 81ST St Street Miami, FL 33143 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 6860 SW 81ST St Street 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 | 2016-11-28 |
| Decision Date | 2017-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020426 | K163326 | 000 |