The following data is part of a premarket notification filed by Electrical Geodesics, Incorporated with the FDA for Geodesic Eeg System 300.
| Device ID | K063797 |
| 510k Number | K063797 |
| Device Name: | GEODESIC EEG SYSTEM 300 |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | ELECTRICAL GEODESICS, INCORPORATED 29611 SIMMONS ROAD Eugene, OR 97405 |
| Contact | Linda J Bovard |
| Correspondent | Linda J Bovard ELECTRICAL GEODESICS, INCORPORATED 29611 SIMMONS ROAD Eugene, OR 97405 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-01-25 |
| Summary: | summary |