The following data is part of a premarket notification filed by Electrical Geodesics, Incorporated with the FDA for Geodesic Photogrammetry System.
| Device ID | K043309 |
| 510k Number | K043309 |
| Device Name: | GEODESIC PHOTOGRAMMETRY SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-01 |
| Decision Date | 2005-01-26 |
| Summary: | summary |