AXON-BUS PROSTHETIC SYSTEM— 510(k) K123795
Substantially EquivalentOtto Bock Austria
FDA 510(k) clearance K123795 for AXON-BUS PROSTHETIC SYSTEM, Substantially Equivalent on 2014-06-03. Applicant: Otto Bock Austria. Device class: 2.
Clearance details
- Applicant
- Otto Bock Austria
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vienna, AT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.