Comet-PLUS
Standard Polysomnograph With 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 Comet-plus.
Pre-market Notification Details
| Device ID | K172711 |
| 510k Number | K172711 |
| Device Name: | Comet-PLUS |
| Classification | Standard Polysomnograph With 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 | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-08 |
| Decision Date | 2017-11-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830022996 | K172711 | 000 |
| 00382830022323 | K172711 | 000 |
| 00382830022330 | K172711 | 000 |
| 00382830022347 | K172711 | 000 |
| 00382830022392 | K172711 | 000 |
| 00382830022408 | K172711 | 000 |
| 00382830022415 | K172711 | 000 |
| 00382830022422 | K172711 | 000 |
| 00382830022439 | K172711 | 000 |
| 00382830022446 | K172711 | 000 |
| 00382830022774 | K172711 | 000 |
| 00382830022781 | K172711 | 000 |
| 00382830022316 | K172711 | 000 |
Trademark Results [Comet-PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMET-PLUS 85946632 4480399 Live/Registered |
Natus Medical Incorporated 2013-05-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.