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U.S. Department of Health and Human Services

Product Classification

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Device monitor, st segment with alarm
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMLD
Premarket Review 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
Third Party Review Not Third Party Eligible
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