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510(k) K232445

CSF-4 (CSF-4) by Cardiacsense — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2024
Date Received
August 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Cardiacsense

  • K221260 — CSF-3 (January 6, 2023)

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