The following data is part of a premarket notification filed by Interacoustics A/s, Assens with the FDA for Dpoae20 , Eclipse.
| Device ID | K060539 |
| 510k Number | K060539 |
| Device Name: | DPOAE20 , ECLIPSE |
| Classification | Audiometer |
| Applicant | INTERACOUSTICS A/S, ASSENS 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan INTERACOUSTICS A/S, ASSENS 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 | 2006-03-01 |
| Decision Date | 2006-05-30 |