QAQ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2210
Classification
FDA Product Code
QAQ
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. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.