The following data is part of a premarket notification filed by Oticon Corp. with the FDA for Oticon I31 Initiales Hearing Aid.
| Device ID | K862981 |
| 510k Number | K862981 |
| Device Name: | OTICON I31 INITIALES HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON CORP. 29 SCHOOLHOUSE RD. P.O. BOX 6724 Somerset, NJ 08873 |
| Contact | Henning V Falster |
| Correspondent | Henning V Falster OTICON CORP. 29 SCHOOLHOUSE RD. P.O. BOX 6724 Somerset, NJ 08873 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-07 |
| Decision Date | 1986-10-15 |