The following data is part of a premarket notification filed by Oticon A/s with the FDA for Amendments To Multifocus.
| Device ID | K951002 |
| 510k Number | K951002 |
| Device Name: | AMENDMENTS TO MULTIFOCUS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON A/S 73 TILSTEDVEJ Thisted, DK Dk-7700 |
| Contact | P. E Lyregaard |
| Correspondent | P. E Lyregaard OTICON A/S 73 TILSTEDVEJ Thisted, DK Dk-7700 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-09-18 |