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U.S. Department of Health and Human Services

Product Classification
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Device dc-defibrillator, high energy, (including paddles)
Definition PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRK
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type PMA
Regulation Number 870.5300
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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