IdentEvent
Automatic Event Detection Software For Full-montage Electroencephalograph
OPTIMA NEUROSCIENCE, INC.
The following data is part of a premarket notification filed by Optima Neuroscience, Inc. with the FDA for Identevent.
Pre-market Notification Details
| Device ID | K150688 |
| 510k Number | K150688 |
| Device Name: | IdentEvent |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | OPTIMA NEUROSCIENCE, INC. 11930 Research Circle Alachua, FL 32615 |
| Contact | Ryan T. Kern |
| Correspondent | Ryan T. Kern OPTIMA NEUROSCIENCE, INC. 11930 Research Circle Alachua, FL 32615 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-17 |
| Decision Date | 2015-11-05 |
Trademark Results [IdentEvent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDENTEVENT 77590262 3772691 Live/Registered |
OPTIMA NEUROSCIENCE, INC. 2008-10-10 |
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