FDA Product Code QNL: Medium-term Adjunctive Predictive Cardiovascular Indicator
The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.
Leading manufacturers include Edwards Lifesciences, LLC.
List of Medium-term Adjunctive Predictive Cardiovascular Indicator devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Medium-term Adjunctive Predictive Cardiovascular Indicator devices (product code QNL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →