510(k) K103594— PONTO PRO POWER

Substantially Equivalent

Oticon Medical AB

Clearance details

Applicant: Oticon Medical AB
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2010-12-08
Decision date: 2011-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gothenburg, Askim, SE

Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

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.