The following data is part of a premarket notification filed by Oticon Corp. with the FDA for Earette Hearing Aid Opticon Model E28p.
| Device ID | K821987 |
| 510k Number | K821987 |
| Device Name: | EARETTE HEARING AID OPTICON MODEL E28P |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-07 |
| Decision Date | 1982-08-19 |