The following data is part of a premarket notification filed by Electrical Geodesics, Inc. with the FDA for Geodesiceeg System 400 Series (ges 400).
| Device ID | K131882 |
| 510k Number | K131882 |
| Device Name: | GEODESICEEG SYSTEM 400 SERIES (GES 400) |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| 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 | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850033571035 | K131882 | 000 |
| 00850033571011 | K131882 | 000 |
| 00850033571004 | K131882 | 000 |