Natus Quantum
Full-montage Standard Electroencephalograph
NATUS MEDICAL INCORPORATED
The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Natus Quantum.
Pre-market Notification Details
| Device ID | K143440 |
| 510k Number | K143440 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2015-04-20 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830016766 | K143440 | 000 |
| 00382830016322 | K143440 | 000 |
| 00382830016339 | K143440 | 000 |
| 00382830016346 | K143440 | 000 |
| 00382830016353 | K143440 | 000 |
| 00382830016360 | K143440 | 000 |
| 00382830016377 | K143440 | 000 |
| 00382830016438 | K143440 | 000 |
| 00382830016476 | K143440 | 000 |
| 00382830016483 | K143440 | 000 |
| 00382830016698 | K143440 | 000 |
| 00382830016704 | K143440 | 000 |
| 00382830016711 | K143440 | 000 |
| 00382830016728 | K143440 | 000 |
| 00382830016735 | K143440 | 000 |
| 00382830016742 | K143440 | 000 |
| 00382830016759 | K143440 | 000 |
| 00382830016315 | K143440 | 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 |
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