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U.S. Department of Health and Human Services

Product Classification

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Device generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Regulation Description External programmable pacemaker pulse generator.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeJOQ
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1750
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? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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