The following data is part of a premarket notification filed by Bernafon-maico, Inc. with the FDA for Opus 2 - Full Concha Series - Ite.
| Device ID | K974211 |
| 510k Number | K974211 |
| Device Name: | OPUS 2 - FULL CONCHA SERIES - ITE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Ray Enroth |
| Correspondent | Ray Enroth BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1997-12-15 |