Esprit Nova
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Neurozone MSH Incorporated
The following data is part of a premarket notification filed by Neurozone Msh Incorporated with the FDA for Esprit Nova.
Pre-market Notification Details
| Device ID | K182227 |
| 510k Number | K182227 |
| Device Name: | Esprit Nova |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | Neurozone MSH Incorporated 17 Lantern Lane Dundas, CA L9h 6n9 |
| Contact | Daniel Ramirez Rodriguez |
| Correspondent | Daniel Ramirez Rodriguez Neurozone MSH Incorporated 17 Lantern Lane Dundas, CA L9h 6n9 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-16 |
| Decision Date | 2019-01-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627987257502 | K182227 | 000 |
Trademark Results [Esprit Nova]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESPRIT NOVA 97177801 not registered Live/Pending |
Signalitica Inc. 2021-12-17 |
 ESPRIT NOVA 86140480 not registered Dead/Abandoned |
Neurozone Dynamics Inc. 2013-12-11 |
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