PKU — Insulin Pump Secondary Display Class II
FDA product code PKU covers "Insulin Pump Secondary Display", a Class II medical device regulated under 21 CFR 862.1350. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- PKU
- Device Class
- Class II
- Regulation Number
- 862.1350
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.