The following data is part of a premarket notification filed by Optima Neuroscience, Inc. with the FDA for Identevent, Version 1.0g.
| Device ID | K092039 |
| 510k Number | K092039 |
| Device Name: | IDENTEVENT, VERSION 1.0G |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | OPTIMA NEUROSCIENCE, INC. 12337 NW 9TH LANE Newberry, FL 32669 |
| Contact | Paula Wilkerson |
| Correspondent | Paula Wilkerson OPTIMA NEUROSCIENCE, INC. 12337 NW 9TH LANE Newberry, FL 32669 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-10-16 |
| Summary: | summary |