FDA 510(k)

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

Numéro K : K200504 · 2020-07-29

DemandeurMed-El Elektromedizinische Geraete GmbH

Date de décision2020-07-29

Code produitPFO

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is the device name listed in this FDA 510(k) record. The listed applicant is Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K200504. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote?

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K200504.

When did BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote receive FDA 510(k) clearance?

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote received FDA 510(k) clearance on 2020-07-29, under 510(k) number K200504.

Who is the listed applicant for BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote?

The FDA 510(k) record lists Med-El Elektromedizinische Geraete GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote?

The FDA product code for BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is PFO.

Essais cliniques associés

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Autres dossiers indiquant Med-El Elektromedizinische Geraete GmbH en tant que demandeur

K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)K183373Bonebridge K172460Système ADHEAR

Dispositifs connexes (Code : PFO)

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Source officielle

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