Automated Insulin Dosing Device System, Single Hormonal Control
The Automated Insulin Dosing Device System, Single Hormonal Control is an insulin-only automated closed-loop system (artificial pancreas) that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump based on specified thresholds of measured glucose levels. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) given its automated, high-risk insulin delivery function. The product code is OZP, reviewed under the clinical chemistry panel, with no regulation number assigned.
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Basic Information
- Product Code
- OZP
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.