The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Galileo Evoked Potentialre.
| Device ID | K963662 |
| 510k Number | K963662 |
| Device Name: | GALILEO EVOKED POTENTIALRE |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | BIOSOUND, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Wayne Nethercutt |
| Correspondent | Wayne Nethercutt BIOSOUND, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1997-02-26 |
| Summary: | summary |