Device type

Medium-Term Adjunctive Predictive Cardiovascular Indicator

Product code QNL · Class II · 21 CFR 870.2210 · Cardiovascular

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.

FDA classification database