The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Yhe Galileo Pleiade Electroencephalograph.
| Device ID | K923894 |
| 510k Number | K923894 |
| Device Name: | YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Wayne L Nethercutt |
| Correspondent | Wayne L Nethercutt BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1993-03-10 |