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U.S. Department of Health and Human Services

Product Classification
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Device monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMHX
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 Standard
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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