The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Ics Impulse.
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 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ICS IMPULSE 79090517 3964680 Live/Registered |
Natus Medical Incorporated 2010-10-16 |