OTOPLAN— 510(k) K242120
Substantially EquivalentCascination AG
FDA 510(k) clearance K242120 for OTOPLAN, Substantially Equivalent on 2025-04-11. Applicant: Cascination AG. Device class: 2.
Clearance details
- Applicant
- Cascination AG
- Product code
- Code QQE
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bern, CH
Recent devices under product code QQE
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