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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
Premarket Review Office of Cardiovascular Devices (OHT2)
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		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review Not Third Party Eligible
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