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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 Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1025
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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