mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis— 510(k) K241142
Substantially EquivalentMED-EL Elektromedizinische Geräte GmbH
FDA 510(k) clearance K241142 for mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis, Substantially Equivalent on 2025-01-17. Applicant: MED-EL Elektromedizinische Geräte GmbH.
Clearance details
- Applicant
- MED-EL Elektromedizinische Geräte GmbH
- Product code
- Code ETB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Innsbruck, AT
Data sourced from openFDA. This site is unofficial and independent of the FDA.