AIDERA DIASEND— 510(k) K083221

Substantially Equivalent

Aidera AB

FDA 510(k) clearance K083221 for AIDERA DIASEND, Substantially Equivalent on 2009-02-03. Applicant: Aidera AB. Device class: 2.

Clearance details

Applicant: Aidera AB
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2008-10-31
Decision date: 2009-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

Download summary PDF View on FDA.gov ↗

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