The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Opti-amp.
| Device ID | K914876 |
| 510k Number | K914876 |
| Device Name: | OPTI-AMP |
| Classification | Amplifier, Physiological Signal |
| 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 | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1992-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020440 | K914876 | 000 |