510(k) K152067— Ponto bone anchored hearing system
Substantially EquivalentOticon Medical AB
Clearance details
- Applicant
- Oticon Medical AB
- Product code
- Code MAH
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Askim, SE
Adverse events under product code MAH
product code MAH- Injury
- 4,155
- Total
- 4,155
Source: openFDA MAUDE database, through . 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.