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510(k) K191689

EleGARD Patient Positioning System by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio — Product Code FOA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 13, 2020
Date Received: June 25, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Board, Cardiopulmonary
Device Class: Class I
Regulation Number: 880.6080
Review Panel: HO
Submission Type