510(k) K201983
K201983 is an FDA 510(k) premarket notification submitted by Med-El Elektromedizinische Geraete GmbH for the device "BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)". The FDA issued a decision of Substantially Equivalent on October 9, 2020. 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
- October 9, 2020
- Date Received
- July 17, 2020
- 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.