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U.S. Department of Health and Human Services

Product Classification

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Device over-the-counter automated external defibrillator
Regulation Description Automated external defibrillator.
Definition Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation.These devices are intended to be used on suspected victims of sudden cardiac arrest.A person in cardiac arrest is unresponsive and is not breathing normally.The device can be sold over-the-counter without a prescription.The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNSA
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.5310
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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