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U.S. Department of Health and Human Services

Product Classification

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Device system, network and communication, physiological monitors
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMSX
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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