The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Galileo Halley.
| Device ID | K970703 |
| 510k Number | K970703 |
| Device Name: | GALILEO HALLEY |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Gerald A Richardson |
| Correspondent | Gerald A Richardson BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. 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 | 1997-02-26 |
| Decision Date | 1997-05-19 |
| Summary: | summary |