BCI 602 Lifts (1 Mm), BCI Lifts (1 Mm), BCI Lifts (2 Mm & 3 Mm), BCI Lifts (4 Mm)

Active Implantable Bone Conduction Hearing System

Med-El Elektromedizinische Geraete GmbH

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).

Pre-market Notification Details

Device IDK201983
510k NumberK201983
Device Name:BCI 602 Lifts (1 Mm), BCI Lifts (1 Mm), BCI Lifts (2 Mm & 3 Mm), BCI Lifts (4 Mm)
ClassificationActive Implantable Bone Conduction Hearing System
Applicant Med-El Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck,  AT 6020
ContactStephanie Haselwanter
CorrespondentStephanie Haselwanter
Med-El Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck,  AT 6020
Product CodePFO  
CFR Regulation Number874.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-17
Decision Date2020-10-09

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.