BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote— 510(k) K200504

Substantially Equivalent

Med-El Elektromedizinische Geraete GmbH

FDA 510(k) clearance K200504 for BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote, Substantially Equivalent on 2020-07-29. Applicant: Med-El Elektromedizinische Geraete GmbH.

Clearance details

Applicant: Med-El Elektromedizinische Geraete GmbH
Product code: Code PFO
Advisory panel: Ear, Nose, Throat
Date received: 2020-03-02
Decision date: 2020-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Innsbruck, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code PFO

product code PFO

Injury: 2,752
Total: 2,752

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.