510(k) K083221

AIDERA DIASEND by Aidera AB — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2009
Date Received
October 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type