PPW · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2200
Classification
FDA Product Code
PPW
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 cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.