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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)
Regulation Description DC-defibrillator (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 Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type PMA
Regulation Number 870.5300
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible