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U.S. Department of Health and Human Services

Product Classification

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Device electrocardiograph, ambulatory (without analysis)
Regulation Description Medical magnetic tape recorder.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMWJ
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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