The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Opti-amp Dc-powered.
| Device ID | K052060 |
| 510k Number | K052060 |
| Device Name: | OPTI-AMP DC-POWERED |
| Classification | Amplifier, Physiological Signal |
| 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 | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2005-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020266 | K052060 | 000 |
| 00817020020150 | K052060 | 000 |
| 00817020020167 | K052060 | 000 |
| 00817020020174 | K052060 | 000 |
| 00817020020181 | K052060 | 000 |
| 00817020020198 | K052060 | 000 |
| 00817020020204 | K052060 | 000 |
| 00817020020211 | K052060 | 000 |
| 00817020020228 | K052060 | 000 |
| 00817020020235 | K052060 | 000 |
| 00817020020242 | K052060 | 000 |
| 00817020020259 | K052060 | 000 |
| 00817020020143 | K052060 | 000 |