Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
The Pump, Infusion, Insulin, to be Used with Invasive Glucose Sensor is a component of a closed-loop invasive glucose management system designed to deliver insulin in a controlled manner for the management of diabetes mellitus in persons requiring insulin, and it accepts and displays data from the glucose sensor. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to its integration with an invasive glucose sensor and automated insulin delivery. The product code is OYC, reviewed under the clinical chemistry panel, with no regulation number assigned.
Research product code OYC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OYC
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 2
Device Characteristics
Definition
The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.