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U.S. Department of Health and Human Services

Product Classification

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Device tester, defibrillator
Regulation Description Defibrillator tester.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRL
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.5325
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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