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U.S. Department of Health and Human Services

Product Classification

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Device automated external defibrillators (non-wearable)
Regulation Description Automated external defibrillator.
Definition This device is a non-wearable prescription use only aed.These are devices that include automated external defibrillation.Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shcok) 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 with prescription only.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMKJ
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 Standard
Third Party Review Not Third Party Eligible
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