FDA 510(k)

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

K-Nummer: K200504 · 2020-07-29

AntragstellerMed-El Elektromedizinische Geraete GmbH

Entscheidungsdatum2020-07-29

ProduktcodePFO

BeratungsausschussEN

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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