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
| Device Type ID | 920 |
| Device Name | Over-the-counter Automated External Defibrillator |
| Regulation Description | Automated External Defibrillator System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | PMA |
| CFR Regulation Number | 870.5310 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NSA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 920 |
| Device | Over-the-counter Automated External Defibrillator |
| Product Code | NSA |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Automated External Defibrillator System. |
| CFR Regulation Number | 870.5310 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 16 |
Failure Of Device To Self-Test | 8 |
Noise, Audible | 3 |
Device Displays Incorrect Message | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Self-Activation Or Keying | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 32 |