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U.S. Department of Health and Human Services

Product Classification

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Device detector and alarm, arrhythmia
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDSI
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.1025
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM072673.pdf] 
Third Party Review Not Third Party Eligible
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