The following data is part of a premarket notification filed by Excel-tech Ltd. (xltek) with the FDA for Olympic Brainz Monitor.
| Device ID | K123079 |
| 510k Number | K123079 |
| Device Name: | OLYMPIC BRAINZ MONITOR |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIR. Oakville, Ontario, CA L6h 5s1 |
| Contact | Daniel Ramirez |
| Correspondent | Daniel Ramirez EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIR. Oakville, Ontario, CA L6h 5s1 |
| Product Code | OMA |
| Subsequent Product Code | OMB |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-05-08 |
| Summary: | summary |