Natus Quantum
Full-montage Standard Electroencephalograph
Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK)
The following data is part of a premarket notification filed by Natus Medical Incorporated Dba Excel_tech Ltd. (xltek) with the FDA for Natus Quantum.
Pre-market Notification Details
| Device ID | K180181 |
| 510k Number | K180181 |
| Device Name: | Natus Quantum |
| 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 |
| Subsequent Product Code | GYC |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830047289 | K180181 | 000 |
| 00382830059268 | K180181 | 000 |
| 00382830016780 | K180181 | 000 |
| 00382830016469 | K180181 | 000 |
| 00382830016452 | K180181 | 000 |
| 00382830016445 | K180181 | 000 |
| 00382830016421 | K180181 | 000 |
| 00382830016414 | K180181 | 000 |
| 00382830016407 | K180181 | 000 |
| 00382830048453 | K180181 | 000 |
| 00382830048316 | K180181 | 000 |
| 00382830048309 | K180181 | 000 |
| 00382830059275 | K180181 | 000 |
| 00382830059299 | K180181 | 000 |
| 00382830047272 | K180181 | 000 |
| 00382830047265 | K180181 | 000 |
| 00382830047135 | K180181 | 000 |
| 00382830047111 | K180181 | 000 |
| 00382830000147 | K180181 | 000 |
| 00382830000130 | K180181 | 000 |
| 00382830043809 | K180181 | 000 |
| 00382830016391 | K180181 | 000 |
| 00382830016384 | K180181 | 000 |
| 00382830000154 | K180181 | 000 |
| 00382830059305 | K180181 | 000 |
| 00382830048149 | K180181 | 000 |
Trademark Results [Natus Quantum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NATUS QUANTUM 86340624 4953692 Live/Registered |
NATUS MEDICAL INCORPORATED 2014-07-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.