The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Smart-screener (auditory).
| Device ID | K925648 |
| 510k Number | K925648 |
| Device Name: | SMART-SCREENER (AUDITORY) |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | INTELLIGENT HEARING SYSTEMS 10689 N. KENDALL DR. SUITE 315 North Miami, FL 33176 |
| Contact | Edward Miskiel |
| Correspondent | Edward Miskiel INTELLIGENT HEARING SYSTEMS 10689 N. KENDALL DR. SUITE 315 North Miami, FL 33176 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-05-11 |