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510(k) K221901

EleGARD by Advancedcpr Solutions, LLC — Product Code FOA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 29, 2022
Date Received: June 30, 2022
Clearance Type: Special
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