The following data is part of a premarket notification filed by Oticon, Inc. with the FDA for Oticon Digisound Ite.
| Device ID | K973885 |
| 510k Number | K973885 |
| Device Name: | OTICON DIGISOUND ITE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON, INC. 29 SCHOOLHOUSE RD. Somerset, NJ 08873 |
| Contact | Proben Brunved |
| Correspondent | Proben Brunved OTICON, INC. 29 SCHOOLHOUSE RD. 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 | 1997-10-14 |
| Decision Date | 1997-11-04 |