The following data is part of a premarket notification filed by Electrical Geodesics, Incorporated with the FDA for Geodesic Eeg System, Model 200.
| Device ID | K012079 |
| 510k Number | K012079 |
| Device Name: | GEODESIC EEG SYSTEM, MODEL 200 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | ELECTRICAL GEODESICS, INCORPORATED 3636 E. COLUNBINE DR. Phoenix, AZ 85032 -7372 |
| Contact | Robert S Mcquate |
| Correspondent | Robert S Mcquate ELECTRICAL GEODESICS, INCORPORATED 3636 E. COLUNBINE DR. Phoenix, AZ 85032 -7372 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-03 |
| Decision Date | 2001-09-19 |
| Summary: | summary |