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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, pacemaker generator function
Regulation Description Pacemaker generator function analyzer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTC
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.3630
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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