The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Neurolink Ip Model: Pk1117.
| Device ID | K100683 |
| 510k Number | K100683 |
| Device Name: | NEUROLINK IP MODEL: PK1117 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) 2568 BRISTOL CIRCLE Oakville, Ontario, 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 | 2010-03-10 |
| Decision Date | 2010-04-09 |