The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Madsen Zodiac.
| Device ID | K161707 |
| 510k Number | K161707 |
| Device Name: | Madsen Zodiac |
| Classification | Tester, Auditory Impedance |
| Applicant | GN OTOMETRICS Hoerskaetten 9 Taatrup, DK Dk-2630 |
| Contact | Asif Muhammad |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315005688 | K161707 | 000 |
| 05713315005152 | K161707 | 000 |
| 05713315004407 | K161707 | 000 |
| 05713315005541 | K161707 | 000 |
| 05713315005558 | K161707 | 000 |
| 05713315005565 | K161707 | 000 |
| 05713315005572 | K161707 | 000 |
| 05713315005589 | K161707 | 000 |
| 05713315005596 | K161707 | 000 |
| 05713315005602 | K161707 | 000 |
| 05713315005619 | K161707 | 000 |
| 05713315005626 | K161707 | 000 |
| 05713315005633 | K161707 | 000 |
| 05713315005640 | K161707 | 000 |
| 05713315005657 | K161707 | 000 |
| 05713315005664 | K161707 | 000 |
| 05713315005671 | K161707 | 000 |
| 05713315004247 | K161707 | 000 |