Acute Coronary Syndrome Event Detector
FDA product code QBI · Class III (high risk) · Cardiovascular
Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
0510(k) clearances
1PMA approvals
1recalls
Implantimplanted device
PMA approvals
- P150009 Guardian System · CJ Healthtech Holdings, LLC · 04/09/2018
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1140-2025 Class II | Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model…Device reaching End of Service prematurely. | Angel Medical Systems, Inc. | 09/01/2023Open, Classified |