QNL · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2210
Classification
FDA Product Code
QNL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2210
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.