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 | K180421 |
| 510k Number | K180421 |
| 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 5si |
| Contact | Shane Sawall |
| Correspondent | Sanjay Mehta Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, CA L6h 5si |
| Product Code | OMB |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-16 |
| Decision Date | 2018-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830048293 | K180421 | 000 |
| 00382830059541 | K180421 | 000 |
| 00382830061742 | K180421 | 000 |
| 00382830061766 | K180421 | 000 |
| 00382830043380 | K180421 | 000 |
| 00382830047210 | K180421 | 000 |
| 00382830048231 | K180421 | 000 |
| 00382830048255 | K180421 | 000 |
| 00382830048279 | K180421 | 000 |
| 00382830063067 | K180421 | 000 |