The following data is part of a premarket notification filed by Electrical Geodesics, Incorporated with the FDA for Geodesic Eeg System Series 100.
| Device ID | K033399 |
| 510k Number | K033399 |
| Device Name: | GEODESIC EEG SYSTEM SERIES 100 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | ELECTRICAL GEODESICS, INCORPORATED 1630 DUTCH RAVINE COURT Reno, NV 89521 -5160 |
| Contact | Robert S Mcquate |
| Correspondent | Robert S Mcquate ELECTRICAL GEODESICS, INCORPORATED 1630 DUTCH RAVINE COURT Reno, NV 89521 -5160 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2004-08-04 |
| Summary: | summary |