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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, pacemaker generator function, indirect
Regulation Description Indirect pacemaker generator function analyzer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRE
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.3640
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
Third Party Review
Accredited Persons
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