Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS— 510(k) K240614
Substantially EquivalentOticon Medical AB
FDA 510(k) clearance K240614 for Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS, Substantially Equivalent on 2024-07-10. Applicant: Oticon Medical AB. Device class: 2.
Clearance details
- Applicant
- Oticon Medical AB
- Product code
- Code PFO
- Device class
- Class 2
- Regulation
- 21 CFR 874.3340
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Askim, SE
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More clearances from Oticon Medical AB
view allAdverse events under product code PFO
product code PFO- Injury
- 2,752
- Total
- 2,752
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.