The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smartep-assr, Model M811007.
| Device ID | K031051 |
| 510k Number | K031051 |
| Device Name: | SMARTEP-ASSR, MODEL M811007 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | INTELLIGENT HEARING SYSTEMS 7356 S.W. 48 ST. Miami, FL 33155 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 7356 S.W. 48 ST. Miami, FL 33155 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-02 |
| Decision Date | 2004-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020815 | K031051 | 000 |