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U.S. Department of Health and Human Services

Product Classification

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Device dc-defibrillator, low-energy, (including paddles)
Regulation Description DC-defibrillator (including paddles).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeLDD
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.5300
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 Standards
Third Party Review Not Third Party Eligible
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