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510(k) K243566

CardioTag by Cardiosense, Inc. — Product Code DXR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 22, 2025
Date Received: November 18, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ballistocardiograph
Device Class: Class II
Regulation Number: 870.2320
Review Panel: CV
Submission Type