PROVOX VEGA, MODEL 8130-8135— 510(k) K090455

Substantially Equivalent

Atos Medical AB

FDA 510(k) clearance K090455 for PROVOX VEGA, MODEL 8130-8135, Substantially Equivalent on 2009-06-05. Applicant: Atos Medical AB.

Clearance details

Applicant: Atos Medical AB
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 2009-02-23
Decision date: 2009-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horby, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

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.