Automated Insulin Dosing Device System, Single Hormonal Control
OZP · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OZP
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CH
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.