ICS Impulse
Nystagmograph
GN OTOMETRICS
The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Ics Impulse.
Pre-market Notification Details
| Device ID | K151504 |
| 510k Number | K151504 |
| Device Name: | ICS Impulse |
| Classification | Nystagmograph |
| Applicant | GN OTOMETRICS HOERSKAETTEN 9 Taatrup, DK Dk-2630 |
| Contact | Anders Rasmussen |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2015-11-16 |
| Summary: | summary |
Trademark Results [ICS Impulse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICS IMPULSE 79090517 3964680 Live/Registered |
Natus Medical Incorporated 2010-10-16 |
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