BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

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 System, Samba 2 Bb, Symfit 8.0, Samba 2 Go, Samba 2 Remote.

Pre-market Notification Details

Device IDK200504
510k NumberK200504
Device Name:BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
ClassificationActive Implantable Bone Conduction Hearing System
Applicant MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck,  AT 6020
ContactCarolin Ralser
CorrespondentCarolin Ralser
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 Received2020-03-02
Decision Date2020-07-29

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