NSA · Class III · 21 CFR 870.5310

FDA Product Code NSA: Over-the-counter Automated External Defibrillator

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.

1
Total
1
Cleared
162d
Avg days
2004
Since

FDA 510(k) Cleared Over-the-counter Automated External Defibrillator Devices (Product Code NSA)

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

About Product Code NSA - Regulatory Context