QMS · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5600
Classification
FDA Product Code
QMS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.5600
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.