PKP · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5725
Classification
FDA Product Code
PKP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5725
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.