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 | K122550 |
| 510k Number | K122550 |
| Device Name: | ICS IMPULSE |
| Classification | Nystagmograph |
| Applicant | GN OTOMETRICS 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm GN OTOMETRICS 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 | 2012-08-21 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315005862 | K122550 | 000 |
| 05713315008566 | K122550 | 000 |
| 05713315008467 | K122550 | 000 |
| 05713315003271 | K122550 | 000 |
| 05713315008375 | K122550 | 000 |
| 05713315008382 | K122550 | 000 |
| 05713315008399 | K122550 | 000 |
| 05713315008405 | K122550 | 000 |
| 05713315008412 | K122550 | 000 |
| 05713315008368 | K122550 | 000 |
| 05713315003295 | K122550 | 000 |
| 05713315005237 | K122550 | 000 |
| 05713315004148 | K122550 | 000 |
| 05713315004940 | K122550 | 000 |
| 05713315005244 | K122550 | 000 |
| 05713315005268 | K122550 | 000 |
| 05713315005282 | K122550 | 000 |
| 05713315008443 | K122550 | 000 |
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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