Certificates
FDA Premarket Submission 510(k) K163121 registration:
FDA Premarket Submission 510(k) K161968 registration:
FDA Premarket Submission 510(k) K102253 registration:
FDA Premarket Submission 510(k) K113184 registration:
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A Quality Audit demonstrated compliance of the Quality Management System with EN ISO 13485:2016…
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An Audit demonstrated compliance of the Quality Management System with Annex II of the Council Directive 93/42/EEC concerning Medical Devices...
Full size document see here (PDF)