The following data is part of a premarket notification filed by Interacoustics A/s, Assens with the FDA for Rem440.
| Device ID | K050496 |
| 510k Number | K050496 |
| Device Name: | REM440 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | INTERACOUSTICS A/S, ASSENS 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan INTERACOUSTICS A/S, ASSENS 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-04-29 |