Bonebridge

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 Bonebridge.

Pre-market Notification Details

Device IDK183373
510k NumberK183373
Device Name:Bonebridge
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 Received2018-12-06
Decision Date2019-03-07
Summary:summary

Trademark Results [Bonebridge]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BONEBRIDGE
BONEBRIDGE
79084534 4181231 Live/Registered
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
2010-05-03

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