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510(k) K243312

CER-S by Cardiocalm Srl — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
October 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Cardiocalm Srl

  • K213861 — CER-S (April 25, 2022)
  • K193177 — CER-S (August 26, 2020)

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