The following data is part of a premarket notification filed by Natus Medical Incorporated Dba Excel-tech Ltd. (xltek) with the FDA for Natus Brain Monitor Amplifier.
| Device ID | K180290 |
| 510k Number | K180290 |
| Device Name: | Natus Brain Monitor Amplifier |
| Classification | Full-montage Standard 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-01 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830047258 | K180290 | 000 |
| 00382830047241 | K180290 | 000 |
| 00382830047234 | K180290 | 000 |