The following data is part of a premarket notification filed by Excel-tech Ltd. (xltek) with the FDA for Neurolink Ip, Model Pk1113.
| Device ID | K081741 |
| 510k Number | K081741 |
| Device Name: | NEUROLINK IP, MODEL PK1113 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIR. Oakville, Ontario, CA L6h 5s1 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh 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 | 2008-06-19 |
| Decision Date | 2008-10-31 |