The following data is part of a premarket notification filed by Interacoustics As with the FDA for Affinity (cabinet Name), Ac440, Hit440, Or The Combination Of Systems.
| Device ID | K043219 |
| 510k Number | K043219 |
| Device Name: | AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS |
| Classification | Audiometer |
| Applicant | INTERACOUSTICS AS 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan INTERACOUSTICS AS 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2005-02-04 |