The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smartscreener-plus2.
| Device ID | K090579 |
| 510k Number | K090579 |
| Device Name: | SMARTSCREENER-PLUS2 |
| 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 |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020846 | K090579 | 000 |
| 00817020020839 | K090579 | 000 |
| 00817020020822 | K090579 | 000 |
| 00817020020754 | K090579 | 000 |
| 00817020020730 | K090579 | 000 |
| 00817020020716 | K090579 | 000 |