The following data is part of a premarket notification filed by Xltek with the FDA for 84 Channel Eeg.
| Device ID | K014146 |
| 510k Number | K014146 |
| Device Name: | 84 CHANNEL EEG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | XLTEK 2568 BRISTOL CIRCLE Oakville, CA L6h 5s1 |
| Contact | Sonja Markez |
| Correspondent | Sonja Markez XLTEK 2568 BRISTOL CIRCLE Oakville, CA L6h 5s1 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-18 |
| Decision Date | 2002-01-14 |
| Summary: | summary |