The following data is part of a premarket notification filed by Electrical Geodesics, Inc. with the FDA for Geodesic Eeg Mobile 100 (gem 100).
| Device ID | K112353 |
| 510k Number | K112353 |
| Device Name: | GEODESIC EEG MOBILE 100 (GEM 100) |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | ELECTRICAL GEODESICS, INC. 29611 SIMMONS ROAD Eugene, OR 97405 |
| Contact | Linda J Bovard |
| Correspondent | Linda J Bovard ELECTRICAL GEODESICS, INC. 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 | 2011-08-16 |
| Decision Date | 2012-02-17 |
| Summary: | summary |