The following data is part of a premarket notification filed by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bci 602 Lifts (1 Mm), Bci Lifts (1 Mm), Bci Lifts (2 Mm & 3 Mm), Bci Lifts (4 Mm).
| Device ID | K201983 |
| 510k Number | K201983 |
| Device Name: | BCI 602 Lifts (1 Mm), BCI Lifts (1 Mm), BCI Lifts (2 Mm & 3 Mm), BCI Lifts (4 Mm) |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | Med-El Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Contact | Stephanie Haselwanter |
| Correspondent | Stephanie Haselwanter 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 | 2020-07-17 |
| Decision Date | 2020-10-09 |