K240614
- 510(k) number
- K240614
- Device name
- Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
- Applicant
- Oticon Medical AB SE
- Product code
- PFO — Active Implantable Bone Conduction Hearing System
- Decision date
- 2024-07-10
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240614.pdf
Official FDA record: K240614
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.