Product code QNL

Device name
Medium-Term Adjunctive Predictive Cardiovascular Indicator
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.2210
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset