mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit— 510(k) K241269
Substantially EquivalentMED-EL Elektromedizinische Geräte GmbH
FDA 510(k) clearance K241269 for mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit, Substantially Equivalent on 2025-01-17. Applicant: MED-EL Elektromedizinische Geräte GmbH. Device class: 2.
Clearance details
- Applicant
- MED-EL Elektromedizinische Geräte GmbH
- Product code
- Code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Innsbruck, AT
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More clearances from MED-EL Elektromedizinische Geräte GmbH
view all- K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more
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Data sourced from openFDA. This site is unofficial and independent of the FDA.