The following data is part of a premarket notification filed by Oticon, Inc. with the FDA for Digifocus Ite.
| Device ID | K964683 |
| 510k Number | K964683 |
| Device Name: | DIGIFOCUS ITE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON, INC. 29 SCHOOLHOUSE RD. Somerset, NJ 08873 |
| Contact | Preben Brunved |
| Correspondent | Preben 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 | 1996-11-22 |
| Decision Date | 1996-12-12 |
| Summary: | summary |