The following data is part of a premarket notification filed by Med-el Elektromedizinische Geraete Gmbh with the FDA for Adhear System.
| Device ID | K172460 |
| 510k Number | K172460 |
| Device Name: | ADHEAR System |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Contact | Elizabeth Gfoeller |
| Correspondent | Elizabeth Gfoeller Med-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-04-27 |
| Summary: | summary |