OBC BONE ANCHORED HEARING SYSTEM— 510(k) K112053

Substantially Equivalent

Oticon Medical AB

FDA 510(k) clearance K112053 for OBC BONE ANCHORED HEARING SYSTEM, Substantially Equivalent on 2011-11-18. Applicant: Oticon Medical AB.

Clearance details

Applicant: Oticon Medical AB
Product code: Code MAH
Advisory panel: Ear, Nose, Throat
Date received: 2011-07-19
Decision date: 2011-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Askim, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAH

product code MAH

Injury: 4,155
Total: 4,155

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.