510(k) K191457
K191457 is an FDA 510(k) premarket notification submitted by Med-El Elektromedizinische Geraete GmbH for the device "BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)". The FDA issued a decision of Substantially Equivalent on September 18, 2019. The device falls under product code PFO (Active Implantable Bone Conduction Hearing System), a Class II device regulated under 21 CFR 874.3340. Med-El Elektromedizinische Geraete GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2019
- Date Received
- May 31, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Active Implantable Bone Conduction Hearing System
- Device Class
- Class II
- Regulation Number
- 874.3340
- Review Panel
- EN
- Submission Type
An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.