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510(k) K231276

SmartCardia 7L Platform by Smartcardia SA — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2023
Date Received
May 2, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Smartcardia SA

  • K240653 — SmartCardia 7L Platform (MCT) (October 31, 2024)

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  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
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  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)