QNL

Medium-Term Adjunctive Predictive Cardiovascular Indicator

Product code

QNL

Device name

Medium-Term Adjunctive Predictive Cardiovascular Indicator

Device class

Class 2

21 CFR

21 CFR 870.2210

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2024-06-21.

3 summaries are archived here for direct download.