The following data is part of a premarket notification filed by Interacoustics As with the FDA for Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan Imp440, Imp440 Module, Titan Suite.
| Device ID | K083861 |
| 510k Number | K083861 |
| Device Name: | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE |
| Classification | Tester, Auditory Impedance |
| Applicant | INTERACOUSTICS AS DREJERVAENGET 8 Assens, DK Dk-5610 |
| Contact | Hanne Nielsen |
| Correspondent | Hanne Nielsen INTERACOUSTICS AS DREJERVAENGET 8 Assens, DK Dk-5610 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-04-09 |
| Summary: | summary |