The following data is part of a premarket notification filed by Oticon Corp. with the FDA for Earette Hearing Aid Sears #8054.
| Device ID | K810379 |
| 510k Number | K810379 |
| Device Name: | EARETTE HEARING AID SEARS #8054 |
| Classification | Binder, Abdominal |
| Applicant | OTICON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSD |
| CFR Regulation Number | 880.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-13 |
| Decision Date | 1981-03-04 |