MKJ · Class III · 21 CFR 870.5310

FDA Product Code MKJ: Automated External Defibrillators (non-wearable)

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 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 With Prescription Only.

228
Total
228
Cleared
156d
Avg days
1985
Since

FDA 510(k) Cleared Automated External Defibrillators (non-wearable) Devices (Product Code MKJ)

228 devices
1–24 of 228
No devices found for this product code.

About Product Code MKJ - Regulatory Context