The following data is part of a premarket notification filed by Intelligent Hearing Systems with the FDA for Wick Electrode, Model M019260.
| Device ID | K063402 |
| 510k Number | K063402 |
| Device Name: | WICK ELECTRODE, MODEL M019260 |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2006-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817020020037 | K063402 | 000 |