The following data is part of a premarket notification filed by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bonebridge System, Samba 2 Bb, Symfit 8.0, Samba 2 Go, Samba 2 Remote.
| Device ID | K200504 |
| 510k Number | K200504 |
| Device Name: | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Contact | Carolin Ralser |
| Correspondent | Carolin Ralser MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Product Code | PFO |
| CFR Regulation Number | 874.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-07-29 |