PKU · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1350
Classification
FDA Product Code
PKU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1350
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.