Cardiology
Avive Automated External Defibrillator (AED) System
Avive Solutions, Inc.
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.
FDA Submission Metadata
- Submission number
- P210015
- Decision date
- October 2022
- FDA panel
- Cardiovascular
- Product code
- MKJ
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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