The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Aurical Hit.
| Device ID | K122028 |
| 510k Number | K122028 |
| Device Name: | AURICAL HIT |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| 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 | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-10 |
| Decision Date | 2012-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315000188 | K122028 | 000 |
| 05713315000102 | K122028 | 000 |
| 05713315000119 | K122028 | 000 |
| 05713315000126 | K122028 | 000 |
| 05713315000133 | K122028 | 000 |
| 05713315000140 | K122028 | 000 |
| 05713315000157 | K122028 | 000 |
| 05713315000164 | K122028 | 000 |
| 05713315000171 | K122028 | 000 |
| 05713315000096 | K122028 | 000 |