K240155
- 510(k) number
- K240155
- Device name
- Cochlear Osia System
- Applicant
- Cochlear Americas CO · US
- Product code
- PFO — Active Implantable Bone Conduction Hearing System
- Decision date
- 2024-04-18
- Date received
- 2024-01-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240155.pdf
Official FDA record: K240155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.