The following data is part of a premarket notification filed by Interacoustics As with the FDA for Ep15 Software Module, Ep25 Software Module.
| Device ID | K090406 |
| 510k Number | K090406 |
| Device Name: | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-07-22 |
| Summary: | summary |