OYC — Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor Class III
FDA product code OYC covers "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OYC
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
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.