BAHA CORDELLE II— 510(k) K080363
Substantially EquivalentCochlear Bone Anchored Systems AB
FDA 510(k) clearance K080363 for BAHA CORDELLE II, Substantially Equivalent on 2008-04-10. Applicant: Cochlear Bone Anchored Systems AB.
Clearance details
- Applicant
- Cochlear Bone Anchored Systems AB
- Product code
- Code MAH
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
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.