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U.S. Department of Health and Human Services

Product Classification

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Device tester, pacemaker electrode function
Regulation Description Pacemaker electrode function tester.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTA
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.3720
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
Accredited Persons
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