The following data is part of a premarket notification filed by Excel-tech Ltd. (xltek) with the FDA for Trez_hd.
| Device ID | K131266 |
| 510k Number | K131266 |
| Device Name: | TREZ_HD |
| Classification | Full-montage Standard 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-03 |
| Decision Date | 2014-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830043779 | K131266 | 000 |
| 00382830015639 | K131266 | 000 |
| 00382830002530 | K131266 | 000 |
| 00382830047777 | K131266 | 000 |