QUO · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2200
Classification
FDA Product Code
QUO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2200
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.