The following data is part of a premarket notification filed by Oticon Corp. with the FDA for Earette Hearing Aid(behind The Ear Oticon E35f.
| Device ID | K851429 |
| 510k Number | K851429 |
| Device Name: | EARETTE HEARING AID(BEHIND THE EAR OTICON E35F |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON CORP. P.O. BOX 424 29 SCHOOLHOUSE ROAD Somerset, NJ 08 |
| Contact | Preben Brunved |
| Correspondent | Preben Brunved OTICON CORP. P.O. BOX 424 29 SCHOOLHOUSE ROAD Somerset, NJ 08 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-10 |
| Decision Date | 1985-05-29 |