MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS
Device Facts
| Record ID | K955828 |
|---|---|
| Device Name | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS |
| Applicant | Graphic Controls Corp. |
| Product Code | MKJ · Cardiovascular |
| Decision Date | Jul 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5310 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
