K121847 is an FDA 510(k) clearance for the TITAN. This device is classified as a Tester, Auditory Impedance (Class II - Special Controls, product code ETY).
Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on November 29, 2012, 157 days after receiving the submission on June 25, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1090.
| 510(k) Number | K121847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2012 |
| Decision Date | November 29, 2012 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETY - Tester, Auditory Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1090 |