The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Interacoustics Assr, Eclipse System (cabinet Name).
| Device ID | K070696 |
| 510k Number | K070696 |
| Device Name: | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | INTERACOUSTICS A/S 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan INTERACOUSTICS A/S 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-13 |
| Decision Date | 2007-06-29 |
| Summary: | summary |