PYV — Hospital Continuous Glucose Monitoring System Class II
FDA product code PYV covers "Hospital Continuous Glucose Monitoring System", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- PYV
- Device Class
- Class II
- Regulation Number
- 862.1345
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.