Regulatory Approvals, Clearances and Quality Certificates FDA 510(k) Clearance July 2020 FDA 510(k) Clearance December 2016 FDA 510(k) Clearance February 2016 FDA 510(k) Clearance February 2015 ISO 13485: 2016 MDSAP Certification EN ISO 13485:2016 Certification CE Marking Australian TGA Certificate Canada Medical License
