Adjunctive Hemodynamic Indicator With Decision Point
QNV · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2220
Classification
FDA Product Code
QNV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2220
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.