The following data is part of a premarket notification filed by Natus Medical Incorporated Dba Excel-tech Ltd. (xltek) with the FDA for Natus Neuroworks.
| Device ID | K200878 |
| 510k Number | K200878 |
| Device Name: | Natus NeuroWorks |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, CA L6h 5s1 |
| Contact | Sanjay Mehta |
| Correspondent | Sanjay Mehta Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, CA L6h 5s1 |
| Product Code | OMB |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-02 |
| Decision Date | 2020-05-18 |